[The Regulatory Plan and Unified Agenda of Federal Regulatory and Deregulatory Actions]
[The Regulatory Plan]
[From the U.S. Government Printing Office, www.gpo.gov]




                          The Regulatory Plan 


____________________________________________________________________

                INTRODUCTION TO THE FALL 2004 REGULATORY PLAN

                Federal regulation is a fundamental instrument of 
                national policy. It is one of the three major tools -- 
                in addition to spending and taxing -- used to implement 
                policy. It is used to advance numerous public 
                objectives, including homeland security, environmental 
                protection, educational quality, food safety, 
                transportation safety, health care quality, equal 
                employment opportunity, energy security, immigration 
                control, and consumer protection. The Office of 
                Management and Budget's (OMB) Office of Information and 
                Regulatory Affairs (OIRA) is responsible for overseeing 
                and coordinating the Federal Government's regulatory 
                policies.

                The Regulatory Plan is published as part of the fall 
                edition of the Unified Agenda of Federal Regulatory and 
                Deregulatory Actions, and serves as a statement of the 
                Administration's regulatory and deregulatory policies 
                and priorities. The purpose of the Plan is to make the 
                regulatory process more accessible to the public and to 
                ensure that the planning and coordination necessary for 
                a well-functioning regulatory process occurs. The Plan 
                identifies regulatory priorities and contains 
                information about the most significant regulatory 
                actions that agencies expect to undertake in the coming 
                year. An accessible regulatory process enables citizen 
                centered service, which is a vital part of the 
                President's Management Agenda.

                Federal Regulatory Policy

                The Bush Administration supports Federal regulations 
                that are sensible and based on sound science, 
                economics, and the law. Accordingly, the Administration 
                is striving for a regulatory process that adopts new 
                rules when markets fail to serve the public interest, 
                simplifies and modifies existing rules to make them 
                more effective or less costly or less intrusive, and 
                rescinds outmoded rules whose benefits do not justify 
                their costs. In pursuing this agenda, OIRA has adopted 
                an approach based on the principles of regulatory 
                analysis and policy espoused in Executive Order 12866, 
                signed by President Clinton in 1993.

                Effective regulatory policy is not uniformly pro-
                regulation or anti-regulation. It begins with the 
                authority granted under the law. Within the discretion 
                available to the regulating agency by its statutory 
                authority, agencies apply a number of principles 
                articulated in Executive Order 12866 (as well as other 
                orders, such as Executive Order 13211, ``Actions 
                Concerning Regulations That Significantly Affect Energy 
                Supply, Distribution, or Use,'' signed May 18, 2001, 66 
                FR 28355), in order to design regulations that achieve 
                their ends in the most efficient way. This means 
                bringing to bear on the policy problem sound economic 
                principles, the highest quality information, and the 
                best possible science. This is not always an easy task, 
                as sometimes economic and scientific information may 
                point in very different directions, and therefore 
                designing regulations does not mean just the rote 
                application of quantified data to reach policy 
                decisions. In making regulatory decisions, we expect 
                agencies to consider not only benefit and cost items 
                that can be quantified and expressed in monetary units, 
                but also other attributes and factors that cannot be 
                integrated readily in a benefit-cost framework, such as 
                fairness and privacy. However, effective regulation is 
                the result 

[[Page 72652]]

                of the careful use of all available high-
                quality data, and the application of broad principles 
                established by the President.

                In pursuing this goal of establishing an effective, 
                results-oriented regulatory system, the Bush 
                Administration has increased the level of public 
                involvement and transparency in its review and 
                clearance of new and existing regulations.

                For new rulemakings and programs, OIRA has enhanced the 
                transparency of OMB's regulatory review process. OIRA's 
                website now enables the public to find information on 
                rules that are formally under review at OMB, have 
                recently been cleared, or have been returned to 
                agencies for reconsideration. OIRA has also increased 
                the amount of information available on its website. In 
                addition to information on meetings and correspondence, 
                OIRA makes available communications from the OIRA 
                Administrator to agencies, including ``prompt 
                letters,'' ``return letters,'' and ``post clearance 
                letters,'' as well as the Administrator's memorandum to 
                the President's Management Council (September 20, 2001) 
                on presidential review of agency rulemaking by OIRA.

                For existing rulemakings, OIRA has initiated a modest 
                series of calls for reform nominations in 2001, 2002, 
                and 2004. In the draft 2001 annual Report to Congress 
                on the Costs and Benefits of Federal Regulation, OMB 
                asked for suggestions from the public about specific 
                regulations that should be modified in order to 
                increase net benefits to the public. We received 
                suggestions regarding 71 regulations, 23 of which OMB 
                designated as high priorities. After a similar call for 
                reforms in the 2002 draft Report, OMB received 
                recommendations on 316 distinct rules, guidance 
                documents, and paperwork requirements from over 1,700 
                commenters. Of the 156 reform nominations that OMB 
                determined were ripe for consideration by Cabinet-level 
                agencies and the Environmental Protection Agency, 
                agencies have decided to pursue 34 rules and 11 
                guidance documents for reform, are undecided about 26 
                rules and 4 guidance documents, and have decided not to 
                pursue reform of 62 rules and 19 guidance documents at 
                this time. Finally, in the 2004 draft Report, OMB 
                requested public nominations of promising regulatory 
                reforms relevant to the manufacturing sector. In 
                particular, commenters were asked to suggest specific 
                reforms to rules, guidance documents, or paperwork 
                requirements that would improve manufacturing 
                regulation by reducing unnecessary costs, increasing 
                effectiveness, enhancing competitiveness, reducing 
                uncertainty, and increasing flexibility. With the 
                publication of the final 2004 Report, OMB will discuss 
                the next steps in these regulatory reform initiatives 
                and will work closely with the agencies to ensure a 
                robust reform process. For further information, all of 
                these Reports are available on OIRA's website at http:/
                /www.whitehouse.gov/omb/inforeg/regpol.html.

                The Bush Administration has also moved aggressively to 
                establish basic quality performance goals for all 
                information disseminated by Federal agencies, including 
                information disseminated in support of proposed and 
                final regulations. The Federal agencies issued 
                guidelines on October 1, 2002 under the Information 
                Quality Act to ensure the ``quality, objectivity, 
                utility, and integrity'' of all information 
                disseminated by Federal agencies. Under these 
                guidelines, Federal agencies are taking appropriate 
                steps to incorporate the information quality 
                performance standards into agency information 
                dissemination practices, and developing pre-
                dissemination review procedures to substantiate the 
                quality of information before it is disseminated. Under 
                the agency information quality guidelines, ``affected 
                persons'' can request that the agencies correct 
                information if they believe that scientific, technical, 
                economic, statistical or other information disseminated 
                does not meet the agency and OMB standards. If the 
                requestor is dissatisfied with the initial agency 
                response to a correction request, an appeal opportunity 
                is provided 

[[Page 72653]]

                by the agencies. To date, agencies have 
                received and responded to approximately 30 complaints 
                that appear to be stimulated by the Information Quality 
                Law. Although we are still in the early phases of 
                implementation, agencies are aware that ensuring the 
                high quality of government information disseminations 
                is a high priority of the Administration. Further 
                information on OIRA's activities implementing the 
                Information Quality Act is available on OIRA's website 
                at http://www.whitehouse.gov/omb/inforeg/
infopoltech.html.

                As part of its efforts to improve the quality, 
                objectivity, utility, and integrity of information 
                disseminated by the Federal agencies, OMB has proposed 
                guidance to realize the benefits of meaningful peer 
                review of the most important science disseminated by 
                the Federal government. The Bulletin on Peer Review 
                establishes minimum standards for when peer review is 
                required and how intensive the peer review should be 
                for different information. The Bulletin requires the 
                most rigorous form of peer review for highly 
                influential scientific assessments. Further information 
                on peer review is available on OIRA's website at http:/
                /www.whitehouse.gov/omb/inforeg/infopoltech.html.

                In addition, the Administration is currently increasing 
                the impact of OMB's analytical perspective. The OIRA 
                Administrator is using the ``prompt letter'' to 
                agencies as a new way to suggest promising regulatory 
                priorities, and highlight issues that may warrant 
                regulatory attention. Though not meant to have legal 
                authority, these prompt letters are designed to bring 
                issues to the attention of agencies in a transparent 
                manner that permits public scrutiny and debate. Prompt 
                letters may highlight regulations that should be 
                pursued, rescinded, revised, or further investigated. 
                For example, OIRA's first set of prompts has suggested 
                lifesaving opportunities at FDA, NHTSA, OSHA and EPA. 
                In a letter to FDA, OIRA suggested that priority be 
                given to completing a promising rulemaking (started in 
                the previous Administration), to require that food 
                labels report the trans-fatty acid content of foods. 
                (Trans-fats are now recognized as a significant 
                contributor to coronary heart disease.) FDA has now 
                issued a final rule that will require the disclosure of 
                trans-fat content in food labels. Similarly, OSHA has 
                responded to an OIRA prompt letter by notifying each 
                employer in the country of the lifesaving effects and 
                cost-effectiveness of automatic defibrillators, a 
                lifesaving technology designed to save lives during 
                sudden cardiac arrest. A list of all of the prompt 
                letters is available at OIRA's website at http://
www.whitehouse.gov/omb/inforeg/prompt--letter.html.

                In addition to increasing the level of public 
                involvement and transparency in its review of 
                regulations, the Bush Administration has sought to 
                enhance the role of analysis in the development of 
                effective regulations. On September 17, 2003, OMB 
                issued revised guidance to agencies on regulatory 
                analysis.\1\ Key features of the revised guidance 
                include more emphasis on cost-effectiveness, more 
                careful evaluation of qualitative and intangible 
                values, and a greater emphasis on considering the 
                uncertainty inherent in estimates of impact. OIRA was 
                very interested in updating the guidance in light of 
                these and other innovations now commonplace in the 
                research community. The 2004 Regulatory Plan continues 
                OIRA's effort to ensure coordination across Federal 
                agencies in pursuing analytically sound regulatory 
                policies.

                The Administration's 2004 Regulatory Priorities

                With regard to Federal regulation, the Bush 
                Administration's objective is quality, not quantity. 
                Those rules that are adopted promise to be more 
                effective, less intrusive, and more cost-effective in 
                achieving national objectives while demonstrating 
                greater durability in the face of political and legal 
                attack. The Regulatory Plan is integral to enhancing 
                the quality of 

[[Page 72654]]

                Federal regulations, and OMB seeks to 
                ensure that the public is provided with the information 
                needed to understand and comment on the Federal 
                regulatory agenda. Accordingly, the 2004 Regulatory 
                Plan highlights the following themes:

                         Regulations that are particularly good 
                            examples of the Administration's ``smart'' 
                            regulation agenda to streamline regulations 
                            and reporting requirements, which is a key 
                            part of the President's economic plan.

                         Regulations that are of particular 
                            concern to small businesses.

                         Regulations that respond to public 
                            nominations submitted to OMB in 2001 or 
                            2002.

                Conclusion

                Smarter regulatory policies, created through public 
                participation, transparency, and cooperation across 
                Federal agencies, are a key Administration objective. 
                The following department and agency plans provide 
                further information on regulatory priorities. All 
                agencies' plans are a reflection of the 
                Administration's Federal Regulatory Policy objectives, 
                which aim at implementing an effective and results-
                oriented regulatory system.

                ------------

                \1\ See Circular A-4, ``Regulatory Analysis,'' 
                published as part of OMB's 2003 Report to Congress on 
                the Costs and Benefits of Federal Regulations. The 
                report is available on OMB's website at: http://
www.whitehouse.gov/omb/inforeg/2003--cost-ben--final--
rpt.pdf

[[Page 72655]]


                                                                DEPARTMENT OF AGRICULTURE
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                   Identifier     Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
1                National Organic Program: Add Standards for the Organic Certification of Wild Captured Aquatic           0581-AB97       Prerule Stage
                 Animals (TM-01-08)
2                Mandatory Country of Origin Labeling of Beef, Pork, Lamb, Fish, Perishable Agricultural                     0581-AC26 Final Rule Stage
                 Commodities, and Peanuts (LS-03-04)
3                Revision of the Nursery Stock Regulations (Q.37)                                                         0579-AB85       Prerule Stage
4                Foot-and-Mouth Disease; Payment of Indemnity                                                             0579-AB34    Final Rule Stage
5                Chronic Wasting Disease in Elk and Deer; Interstate Movement Restrictions and Payment of Indemnity       0579-AB35    Final Rule Stage
6                Senior Farmers' Market Nutrition Program (SFMNP)                                                         0584-AD35       Proposed Rule
                                                                                                                                                  Stage
7                FSP: Discretionary Quality Control Provisions of Title IV of Public Law 107-171                          0584-AD37       Proposed Rule
                                                                                                                                                  Stage
8                Special Nutrition Programs: Fluid Milk Substitutions                                                     0584-AD58       Proposed Rule
                                                                                                                                                  Stage
9                Child and Adult Care Food Program: Improving Management and Program Integrity                               0584-AC24 Final Rule Stage
10               Commodity Supplemental Food Program (CSFP): Plain Language, Program Accountability, and Program             0584-AC84 Final Rule Stage
                 Flexibility
11               FSP: High Performance Bonuses                                                                            0584-AD29    Final Rule Stage
12               FSP: Eligibility and Certification Provisions of the Farm Security and Rural Investment Act of 2002      0584-AD30    Final Rule Stage
13               FSP: Non-Discretionary Quality Control Provisions of Title IV of Public Law 107-171                      0584-AD31    Final Rule Stage
14               FSP: Employment and Training Program Provisions of the Farm Security and Rural Investment Act of         0584-AD32    Final Rule Stage
                 2002
15               Direct and Discretionary Certification in the School Meals Programs                                      0584-AD60    Final Rule Stage
16               Performance Standards for Pumped or Massaged Bacon                                                          0583-AC49    Proposed Rule
                                                                                                                                                  Stage
17               Egg Products Inspection Regulations                                                                         0583-AC58    Proposed Rule
                                                                                                                                                  Stage
18               Food Standards; General Principles and Food Standards Modernization                                         0583-AC72    Proposed Rule
                                                                                                                                                  Stage
19               Performance Standard for Chilling of Ready-To-Cook Poultry                                                  0583-AC87    Proposed Rule
                                                                                                                                                  Stage
20               Performance Standards for the Production of Processed Meat and Poultry Products                             0583-AC46 Final Rule Stage
21               Nutrition Labeling of Single-Ingredient Products and Ground or Chopped Meat and Poultry Products            0583-AC60 Final Rule Stage
22               Prohibition of the Use of Specified Risk Materials for Human Food and Requirements for the                  0583-AC88 Final Rule Stage
                 Disposition of Non-Ambulatory Disabled Cattle
23               State Petitions for Inventoried Roadless Area Management                                                    0596-AC10    Proposed Rule
                                                                                                                                                  Stage
24               National Forest System Land Management Planning                                                          0596-AB86    Final Rule Stage
25               Emergency Watershed Protection Program                                                                   0578-AA30    Final Rule Stage
26               Technical Service Provider Assistance                                                                    0578-AA35    Final Rule Stage
27               Conservation Security Program                                                                            0578-AA36    Final Rule Stage
28               Grassland Reserve                                                                                        0578-AA38    Final Rule Stage
29               Confidentiality of Conservation Program Information                                                      0578-AA40    Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                                 DEPARTMENT OF COMMERCE
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                   Identifier     Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
30               Designate Critical Habitat for 7 Evolutionarily Significant Units (ESUs) of Pacific Salmon and           0648-AO04       Proposed Rule
                 Steelhead in California                                                                                                          Stage
31               Designate Critical Habitat for 13 Evolutionarily Significant Units (ESUs) of Pacific Salmon and          0648-AQ77       Proposed Rule
                 Steelhead in Washington, Oregon and Idaho                                                                                        Stage
32               Amendments 18 and 19 to the Fishery Management Plan for Bering Sea/Aleutian Islands King and Tanner      0648-AS47       Proposed Rule
                 Crabs--Crab Rationalization Program                                                                                              Stage

[[Page 72656]]

 
33               Northwest Hawaiian Islands National Marine Sanctuary; Designation and Implementation of Regulations      0648-AS83       Proposed Rule
                                                                                                                                                  Stage
34               Listing Determinations for 27 Evolutionarily Significant Units (ESUs) of West Coast Salmon and           0648-AR93    Final Rule Stage
                 Oncorhynchus Mykiss
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                                 DEPARTMENT OF EDUCATION
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                   Identifier     Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
35               Reauthorization of the Individuals With Disabilities Education Act                                       1820-AB54       Prerule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                                  DEPARTMENT OF ENERGY
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                   Identifier     Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
36               Energy Efficiency Standards for Residential Furnaces and Boilers                                         1904-AA78       Proposed Rule
                                                                                                                                                  Stage
37               Energy Efficiency Standards for Electric Distribution Transformers                                       1904-AB08       Proposed Rule
                                                                                                                                                  Stage
38               Energy Efficiency Standards for Commercial Unitary Air Conditioners and Heat Pumps                       1904-AB09       Proposed Rule
                                                                                                                                                  Stage
39               Worker Safety and Health                                                                                 1901-AA99       Proposed Rule
                                                                                                                                                  Stage
40               Radiation Protection of the Public and the Environment                                                   1901-AA38    Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                         DEPARTMENT OF HEALTH AND HUMAN SERVICES
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                   Identifier     Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
41               Food Labeling; Prominence of Calories                                                                    0910-AF22       Prerule Stage
42               Food Labeling; Serving Sizes of Products That Can Reasonably Be Consumed at One Eating Occasion;         0910-AF23       Prerule Stage
                 Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion
                 Sizes
43               Foreign and Domestic Establishment Registration and Listing Requirements for Human Drugs, Certain        0910-AA49       Proposed Rule
                 Biological Drugs, and Animal Drugs                                                                                               Stage
44               Substances Prohibited From Use in Animal Food or Feed                                                    0910-AF46       Proposed Rule
                                                                                                                                                  Stage
45               Use of Materials Derived From Cattle In Human and Animal Medical Products                                0910-AF54       Proposed Rule
                                                                                                                                                  Stage
46               Requirements for Human and Animal Medical Products Manufactured From, Processed With, or Otherwise       0910-AF55       Proposed Rule
                 Containing Material From Cattle                                                                                                  Stage
47               Requirements on Content and Format of Labeling for Human Prescription Drugs and Biological Products      0910-AA94    Final Rule Stage
48               Safety Reporting Requirements for Human Drug and Biological Products                                     0910-AA97    Final Rule Stage
49               Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product               0910-AB28    Final Rule Stage
                 Establishments; Inspection and Enforcement
50               CGMPs for Blood and Blood Components: Notification of Consignees and Transfusion Recipients              0910-AB76    Final Rule Stage
                 Receiving Blood and Blood Components at Increased Risk of Transmitting HCV Infection (Lookback)
51               Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and        0910-AB88    Final Rule Stage
                 Dietary Supplements
52               Prevention of Salmonella Enteritidis in Shell Eggs                                                          0910-AC14 Final Rule Stage
53               Toll-Free Number for Reporting Adverse Events on Labeling for Human Drugs                                   0910-AC35 Final Rule Stage

[[Page 72657]]

 
54               Establishment and Maintenance of Records Pursuant to the Public Health Security and Bioterrorism            0910-AC39 Final Rule Stage
                 Preparedness and Response Act of 2002
55               Registration of Food and Animal Feed Facilities                                                             0910-AC40 Final Rule Stage
56               Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and            0910-AC41 Final Rule Stage
                 Response Act of 2002
57               Use of Ozone-Depleting Substances: Removal of Essential Use Designation; Albuterol                       0910-AF18    Final Rule Stage
58               Use of Materials Derived From Cattle in Human Food and Cosmetics                                         0910-AF47    Final Rule Stage
59               Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed With, or            0910-AF48    Final Rule Stage
                 Otherwise Containing Material From Cattle
60               End Stage Renal Disease (ESRD) Conditions for Coverage (CMS-3818-P)                                      0938-AG82       Proposed Rule
                                                                                                                                                  Stage
61               Hospital Conditions of Participation: Requirements for Approval and Reapproval of Transplant             0938-AH17       Proposed Rule
                 Centers To Perform Organ Transplants (CMS-3835-P)                                                                                Stage
62               Hospice Care--Conditions of Participation (CMS-3844-P)                                                   0938-AH27       Proposed Rule
                                                                                                                                                  Stage
63               Organ Procurement Organization Conditions for Coverage (CMS-3064-P)                                      0938-AK81       Proposed Rule
                                                                                                                                                  Stage
64               Use of Restraint and Seclusion in Medicare and Medicaid Participating Facilities That Provide            0938-AL26       Proposed Rule
                 Inpatient or Residential Care (CMS-2130-P)                                                                                       Stage
65               Revisions to the Oversight and Validation Program for Accrediting Organizations Approved for             0938-AN62       Proposed Rule
                 Deeming Authority (CMS-2255-P)                                                                                                   Stage
66               Medicare Advantage Program--Title II (CMS-4069-F)                                                        0938-AN06    Final Rule Stage
67               Medicare Drug Benefit Effective Calendar Year 2006--Title I (CMS-4068-F)                                 0938-AN08    Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                             DEPARTMENT OF HOMELAND SECURITY
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                   Identifier     Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
68               Homeland Security Information Sharing                                                                    1601-AA25       Proposed Rule
                                                                                                                                                  Stage
69               Procedures for Handling Critical Infrastructure Information                                              1601-AA14    Final Rule Stage
70               Regulations Implementing the Support Antiterrorism by Fostering Effective Technologies Act of 2002       1601-AA15    Final Rule Stage
                 (the SAFETY Act)
71               Department of Homeland Security (DHS) Human Resources Management System                                  1601-AA21    Final Rule Stage
72               Commercial Fishing Industry Vessels (USCG-2003-16158)                                                    1625-AA77       Proposed Rule
                                                                                                                                                  Stage
73               Post Casualty Drug and Alcohol Testing (USCG-2001-8773)                                                  1625-AA27    Final Rule Stage
74               United States Visitor and Immigrant Status Indicator Technology Program (US-VISIT); Auth. To             1650-AA00    Final Rule Stage
                 Collect Biometric Data From Addit'l Travelers and Expansion to 50 Most Highly Trafficked Land
                 Border Ports
75               Establishing Procedures for Recertification of Schools Approved by the Student and Exchange Visitor      1653-AA42       Prerule Stage
                 Program (SEVP) to Enroll F or M Nonimmigrant Students
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                       DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                   Identifier     Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
76               Consolidated Plan Amendments (FR-4923)                                                                   2501-AD07       Proposed Rule
                                                                                                                                                  Stage
77               Treble Damages for Failure To Engage in Loss Mitigation (FR-4553)                                           2501-AC66 Final Rule Stage
78               Housing Counseling Program (FR-4798)                                                                     2502-AH99       Proposed Rule
                                                                                                                                                  Stage
79               Empowerment Zones: Resident Benefit and Economic Development Standards for Grants (FR-4853)                 2506-AC16    Proposed Rule
                                                                                                                                                  Stage

[[Page 72658]]

 
80               Capital Fund Program (FR-4880)                                                                              2577-AC50    Proposed Rule
                                                                                                                                                  Stage
81               Operating Fund Allocation Formula (FR-4874)                                                                 2577-AC51    Proposed Rule
                                                                                                                                                  Stage
82               Native American Housing Assistance and Self-Determination Act (NAHASDA): Revisions to the Indian            2577-AC57    Proposed Rule
                 Housing Block Grant Program Formula (FR-4938)                                                                                    Stage
83               Project-Based Voucher Program (FR-4636)                                                                     2577-AC25 Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                               DEPARTMENT OF THE INTERIOR
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                   Identifier     Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
84               Valuation of Oil From Indian Leases                                                                      1010-AD00       Proposed Rule
                                                                                                                                                  Stage
85               Grazing Administration--Exclusive of Alaska                                                              1004-AD42    Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                                  DEPARTMENT OF JUSTICE
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                   Identifier     Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
86               Nondiscrimination on the Basis of Disability in Public Accommodations and Commercial Facilities          1190-AA44       Prerule Stage
87               Nondiscrimination on the Basis of Disability in State and Local Government Services                      1190-AA46       Prerule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                                   DEPARTMENT OF LABOR
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                   Identifier     Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
88               Family and Medical Leave Act of 1993; Conform to the Supreme Court's Ragsdale Decision                   1215-AB35       Proposed Rule
                                                                                                                                                  Stage
89               Child Labor Regulations, Orders, and Statements of Interpretation (ESA/W-H)                              1215-AA09    Final Rule Stage
90               Revision to the Department of Labor Benefit Regulations for Trade Adjustment Assistance for Workers      1205-AB32       Proposed Rule
                 Under the Trade Act of 1974, as Amended                                                                                          Stage
91               Revision to the Department of Labor Regulations for Petitions and Determinations of Eligibility To       1205-AB40       Proposed Rule
                 Apply for Trade Adjustment Assistance for Workers and Issuance of Regulations for the Alternative                                Stage
                 TAA
92               Labor Certification Process for the Permanent Employment of Aliens in the United States                  1205-AA66    Final Rule Stage
93               Rulemaking Relating to Termination of Abandoned Individual Account Plans                                 1210-AA97       Proposed Rule
                                                                                                                                                  Stage
94               Amendment of Regulation Relating to Definition of Plan Assets--Participant Contributions                 1210-AB02       Proposed Rule
                                                                                                                                                  Stage
95               Regulations Implementing the Health Care Access, Portability, and Renewability Provisions of the         1210-AA54    Final Rule Stage
                 Health Insurance Portability and Accountability Act of 1996
96               Prohibiting Discrimination Against Participants and Beneficiaries Based on Health Status                 1210-AA77    Final Rule Stage
97               Asbestos Exposure Limit                                                                                  1219-AB24       Proposed Rule
                                                                                                                                                  Stage
98               Diesel Particulate Matter Exposure of Underground Metal and Nonmetal Miners                              1219-AB29    Final Rule Stage
99               Occupational Exposure to Crystalline Silica                                                              1218-AB70       Prerule Stage
100              Occupational Exposure to Hexavalent Chromium (Preventing Occupational Illness: Chromium)                 1218-AB45       Proposed Rule
                                                                                                                                                  Stage

[[Page 72659]]

 
101              Assigned Protection Factors: Amendments to the Final Rule on Respiratory Protection                      1218-AA05    Final Rule Stage
102              Standards Improvement (Miscellaneous Changes) for General Industry, Marine Terminals, and                1218-AB81    Final Rule Stage
                 Construction Standards (Phase II)
103              Uniformed Services Employment and Reemployment Rights Act Regulations                                    1293-AA09       Proposed Rule
                                                                                                                                                  Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                              DEPARTMENT OF TRANSPORTATION
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                   Identifier     Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
104              Aging Aircraft Program (Widespread Fatigue Damage)                                                       2120-AI05       Proposed Rule
                                                                                                                                                  Stage
105              Enhanced Airworthiness Program for Airplane Systems (EAPAS) and SFAR 88                                  2120-AI31       Proposed Rule
                                                                                                                                                  Stage
106              Aging Aircraft Safety--Development of TC and STC Holder Data                                             2120-AI32       Proposed Rule
                                                                                                                                                  Stage
107              Flight Simulation Device Qualification                                                                   2120-AH07    Final Rule Stage
108              Transport Airplane Fuel Tank Flammability Reduction                                                      2120-AI23    Final Rule Stage
109              Unified Registration System                                                                              2126-AA22       Proposed Rule
                                                                                                                                                  Stage
110              Hours of Service of Drivers; Supporting Documents                                                        2126-AA76       Proposed Rule
                                                                                                                                                  Stage
111              Tire Pressure Monitoring Systems                                                                         2127-AJ23       Proposed Rule
                                                                                                                                                  Stage
112              Whistle Bans at Highway-Rail Grade Crossings                                                             2130-AA71    Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                               DEPARTMENT OF THE TREASURY
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                   Identifier     Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
113              Implementation of a Revised Basel Capital Accord (Basel II)                                                 1557-AC91    Proposed Rule
                                                                                                                                                  Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                             DEPARTMENT OF VETERANS AFFAIRS
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                   Identifier     Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
114              Enrollment--Provision of Hospital and Outpatient Care to Veterans--Subpriorities of Priority             2900-AL51    Final Rule Stage
                 Categories 7 and 8 and Enrollment Level Decision
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                             ENVIRONMENTAL PROTECTION AGENCY
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                   Identifier     Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
115              Endocrine Disruptor Screening Program (EDSP); Chemical Selection Approach for Initial Round of           2070-AD59       Prerule Stage
                 Screening
116              Notification of Chemical Exports Under TSCA Section 12(b)                                                2070-AJ01       Prerule Stage
117              Lead-Based Paint Activities; Voluntary Program for Renovation and Remodeling                             2070-AJ03       Prerule Stage
118              Clean Air Fine Particle Implementation Rule                                                              2060-AK74       Proposed Rule
                                                                                                                                                  Stage
119              Prevention of Significant Deterioration (PSD) and Nonattainment New Source Review (NSR): Allowables      2060-AL75       Proposed Rule
                 Plantwide Applicability Limit (PAL), Aggregation, and Debottlenecking                                                            Stage

[[Page 72660]]

 
120              Pesticides; Data Requirements for Conventional Chemicals                                                    2070-AC12    Proposed Rule
                                                                                                                                                  Stage
121              Pesticides; Emergency Exemption Process Revisions                                                        2070-AD36       Proposed Rule
                                                                                                                                                  Stage
122              Acceptability of Research Using Human Subjects                                                           2070-AD57       Proposed Rule
                                                                                                                                                  Stage
123              Increase Metals Reclamation From F006 Waste Streams                                                      2050-AE97       Proposed Rule
                                                                                                                                                  Stage
124              Regulatory Amendments to the F019 Hazardous Waste Listing To Exclude Wastewater Treatment Sludges        2050-AG15       Proposed Rule
                 From Chemical Conversion Coating Process (Zinc Phosphating) of Automobile Bodies of Aluminum                                     Stage
125              Toxics Release Inventory Reporting Burden Reduction Rule                                                 2025-AA14       Proposed Rule
                                                                                                                                                  Stage
126              Clean Air Visibility Rule                                                                                2060-AJ31    Final Rule Stage
127              Clean Air Mercury Rule--Electric Utility Steam Generating Units                                          2060-AJ65    Final Rule Stage
128              Clean Air Ozone Implementation Rule (Part 1 and Part 2)                                                  2060-AJ99    Final Rule Stage
129              Nonattainment Major New Source Review (NSR)                                                              2060-AM59    Final Rule Stage
130              Test Rule; Testing of Certain High Production Volume (HPV) Chemicals                                     2070-AD16    Final Rule Stage
131              NESHAPS: Standards for Hazardous Air Pollutants for Hazardous Waste Combustors (Phase I Final            2050-AE01    Final Rule Stage
                 Replacement Standards and Phase II)
132              Hazardous Waste Manifest Regulation                                                                      2050-AE21    Final Rule Stage
133              Standardized Permit for RCRA Hazardous Waste Management Facilities                                       2050-AE44    Final Rule Stage
134              RCRA Burden Reduction Initiative                                                                         2050-AE50    Final Rule Stage
135              Recycling of Cathode Ray Tubes (CRTs): Changes to Hazardous Waste Regulations                            2050-AE52    Final Rule Stage
136              Hazardous Waste Management System; Modification of the Hazardous Waste Program: Mercury-Containing       2050-AG21    Final Rule Stage
                 Equipment
137              National Primary Drinking Water Regulations: Groundwater Rule                                            2040-AA97    Final Rule Stage
138              National Primary Drinking Water Regulations: Long Term 2 Enhanced Surface Water Treatment Rule           2040-AD37    Final Rule Stage
139              National Primary Drinking Water Regulations: Stage 2 Disinfection Byproducts Rule                        2040-AD38    Final Rule Stage
140              Minimizing Adverse Environmental Impact From Cooling Water Intake Structures at Existing Facilities      2040-AD70    Final Rule Stage
                 Under Section 316(b) of the Clean Water Act, Phase 3
141              Cross-Media Electronic Reporting (ER) and Recordkeeping Rule (CROMERRR)                                  2025-AA07    Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                         EQUAL EMPLOYMENT OPPORTUNITY COMMISSION
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                   Identifier     Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
142              Coordination of Retiree Health Benefits With Medicare and State Health Benefits                          3046-AA72    Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                      NATIONAL ARCHIVES AND RECORDS ADMINISTRATION
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                   Identifier     Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
143              Federal Records Management                                                                               3095-AB16       Proposed Rule
                                                                                                                                                  Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                          PENSION BENEFIT GUARANTY CORPORATION
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                   Identifier     Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
144              Allocation of Assets in Single-Employer Plans; Valuation of Benefits and Assets                          1212-AA55       Proposed Rule
                                                                                                                                                  Stage
145              Transparency of Information Related to Plan Liabilities                                                  1212-AB01       Proposed Rule
                                                                                                                                                  Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 72661]]


                                                              SMALL BUSINESS ADMINISTRATION
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                   Identifier     Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
146              Small Business Lending Companies Regulations                                                             3245-AE14       Proposed Rule
                                                                                                                                                  Stage
147              Proposed Small Business Innovation Research (SBIR) Policy Directive                                      3245-AF21       Proposed Rule
                                                                                                                                                  Stage
148              Small Business Technology Transfer Program Policy Directive                                              3245-AE96    Final Rule Stage
149              Small Business Government Contracting Programs                                                           3245-AF12    Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                             SOCIAL SECURITY ADMINISTRATION
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                   Identifier     Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
150              Privacy and Disclosure of Official Records and Information (711P)                                        0960-AE88       Proposed Rule
                                                                                                                                                  Stage
151              Federal Salary Offset (Withholding a Portion of a Federal Employee's Salary To Collect a Delinquent      0960-AE89       Proposed Rule
                 Debt Owed to the Social Security Administration) (721P)                                                                          Stage
152              Exemption of Work Activity as a Basis for a Continuing Disability Review (Ticket to Work and Work        0960-AE93       Proposed Rule
                 Incentives Improvement Act of 1999) (725P)                                                                                       Stage
153              Revised Medical Criteria for Evaluating Immune System Disorders (804P)                                   0960-AF33       Proposed Rule
                                                                                                                                                  Stage
154              Amendments to the Ticket to Work and Self-Sufficiency Program (967P)                                     0960-AF89       Proposed Rule
                                                                                                                                                  Stage
155              Elimination of Parent-to-Child Deeming for Individuals Who No Longer Meet the Definition of Spouse       0960-AF96       Proposed Rule
                 of the Natural or Adoptive Parent (793P)                                                                                         Stage
156              Rules for Helping Blind and Disabled Individuals Achieve Self-Support (506P)                             0960-AG00       Proposed Rule
                                                                                                                                                  Stage
157              Medicare Prescription Drug Premium and Cost-Sharing (1024P)                                              0960-AG03       Proposed Rule
                                                                                                                                                  Stage
158              Civil Monetary Penalties, Assessments, and Recommended Exclusions (2362P)                                0960-AG08       Proposed Rule
                                                                                                                                                  Stage
159              Representative Payment; Additional Protections for Persons With Representative Payees (2422P)            0960-AG09       Proposed Rule
                                                                                                                                                  Stage
160              Issuance of Work Report Receipts, Payment of Trial Work Period Months After a Fraud Conviction and       0960-AG10       Proposed Rule
                 Changes to the Student Earned Income Exclusion (2502P)                                                                           Stage
161              Income Related Medicare Part B Premium Subsidy Reduction (2101P)                                         0960-AG11       Proposed Rule
                                                                                                                                                  Stage
162              Denial of Title II Benefits to Persons Fleeing Prosecution, Custody, or Confinement, and to Persons      0960-AG12       Proposed Rule
                 Violating Probation or Parole (2222P)                                                                                            Stage
163              Privacy and Disclosure of Official Records and Information; Availability of Information and Records      0960-AG14       Proposed Rule
                 to the Public (2562P)                                                                                                            Stage
164              Revised Medical Criteria for Evaluating Malignant Neoplastic Diseases (399F)                             0960-AD67    Final Rule Stage
165              Elimination of Clothing From the Definitions of Income and In-Kind Support and Maintenance,              0960-AF84    Final Rule Stage
                 Exclusions of One Automobile, and Household Goods and Personal Effects Under SSI From Resources
                 (950F)
166              Continuation of Benefit Payments to Certain Individuals Who Are Participating in a Program of            0960-AF86    Final Rule Stage
                 Vocational Rehabilitation Services, Employment Services, or Other Support Services (925F)
167              Administrative Review Process; Incorporation by Reference of Oral Findings of Fact and Rationale in      0960-AF92    Final Rule Stage
                 Wholly Favorable Written Decisions (964I)
168              Expanded Authority for Cross-Program Recovery of Benefit Overpayments (2221F)                            0960-AG06    Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 72662]]


                                                           CONSUMER PRODUCT SAFETY COMMISSION
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                   Identifier     Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
169              Flammability Standard for Upholstered Furniture                                                          3041-AB35       Proposed Rule
                                                                                                                                                  Stage
170              Proposed Standard To Address Open-Flame Ignition of Mattresses/Bedding                                      3041-AC02    Proposed Rule
                                                                                                                                                  Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


[FR Doc. 04-26308 Filed 12-10-04; 8:45 am]
BILLING CODE 6820-27-S

[[Page 72663]]




DEPARTMENT OF AGRICULTURE (USDA)

Statement of Regulatory Priorities
 USDA is a primary issuer of regulations within the Federal Government 
covering a broad range of issues. Within the rulemaking process is the 
department-wide effort to reduce burden on participants and program 
administrators alike by focusing on improving program outcomes, and 
particularly on achieving the performance measures specified in the 
USDA and agency Strategic Plans. Significant focus is being placed on 
efficiencies that can be achieved through eGov activities, the 
migration to efficient electronic services and capabilities, and the 
implementation of focused, efficient information collections necessary 
to support effective program management. Important areas of activity 
include the following:
 USDA will develop new regulations and review existing 
            regulations to prevent the introduction or spread of pests 
            and diseases into the United States. In addition, it will 
            continue to work to minimize impediments to trade while 
            protecting U.S. animal and plant resources.
 In the area of food safety, USDA will continue to develop 
            science-based regulations that improve the safety of meat, 
            poultry, and egg products in the least burdensome and most 
            cost-effective manner. Regulations will be revised to 
            address emerging food safety challenges, streamlined to 
            remove excessively prescriptive regulations, and updated to 
            be made consistent with hazard analysis and critical 
            control point principles.
 As changes are made for the nutrition assistance programs, 
            USDA will work to foster actions that will help improve 
            diets and particularly to prevent and reduce overweight and 
            obesity. In 2005, this will include implementing 
            refinements to the nutrition assistance programs included 
            in reauthorization statutes as well as additional changes 
            that will promote healthful eating and physical activity, 
            while also improving the efficiency and integrity of 
            program operations.
 USDA will continue to finalize rulemaking related to 
            implementing the Farm Security and Rural Investment Act of 
            2002 (Farm Bill). Some of the Farm Bill rules have already 
            been issued in final including those for the Conservation 
            Reserve Program and the Environmental Quality Incentives 
            Program. Other programs, such as the Conservation Security 
            Program and the Grasslands Reserve Program, were 
            implemented with interim final rules on which the public 
            has submitted comments. Our focus in 2005 will be to make 
            clarifications and modifications in response to these 
            comments and to promulgate these rules in final.
Reducing Paperwork Burden on Customers
 USDA has made substantial progress in implementing the goal of the 
Paperwork Reduction Act of 1995 to reduce the burden of information 
collection on the public. To meet the requirements of the Government 
Paperwork Elimination Act (GPEA), agencies across USDA are providing 
electronic alternatives to their traditionally paper-based customer 
transactions. As a result, producers increasingly have the option to 
electronically file forms and all other documentation online. To 
facilitate the expansion of electronic government and promote 
compliance with GPEA, USDA implemented an electronic authentication 
capability that allows customers to ``sign-on'' once and conduct 
business with all USDA agencies. Underlying these efforts are ongoing 
analyses to identify and eliminate redundant data collections and 
streamline collection instructions. The end result of implementing 
these initiatives is better service to our customers enabling them to 
choose when and where to conduct business with USDA.
The Role of Regulations
 The programs of USDA are diverse and far reaching, as are the 
regulations that attend their delivery. Regulations codify how USDA 
will conduct its business, including the specifics of access to, and 
eligibility for, USDA programs. Regulations also specify the 
responsibilities of State and local governments, private industry, 
businesses, and individuals that are necessary to comply with their 
provisions.
 The diversity in purpose and outreach of our programs contributes 
significantly to USDA being near the top of the list of departments 
that produce the largest number of regulations annually. These 
regulations range from nutrition standards for the school lunch 
program, to natural resource and environmental measures governing 
national forest usage and soil conservation, to regulations protecting 
American agribusiness (the largest dollar value contributor to exports) 
from the ravages of domestic or foreign plant or animal pestilence, and 
they extend from farm to supermarket to ensure the safety, quality, and 
availability of the Nation's food supply.
 Many regulations function in a dynamic environment, which requires 
their periodic modification. The factors determining various 
entitlement, eligibility, and administrative criteria often change from 
year to year. Therefore, many significant regulations must be revised 
annually to reflect changes in economic and market benchmarks.
 Almost all legislation that affects USDA programs has accompanying 
regulatory needs, often with a significant impact. The Farm Security 
and Rural Investment Act of 2002, Public Law 107-171; the Child 
Nutrition and WIC Reauthorization Act of 2004, Public Law 108-265; and 
the Agricultural Risk Protection Act of 2000, Public Law 106-224, 
affect most agencies of USDA resulting in the modification, addition, 
or deletion of many programs. These statutes set in motion rulemakings 
that provide for improvements in market loss and conservation 
assistance, crop and livestock disease and pest protection, marketing 
enhancements, pollution control, research and development for biomass, 
and refinements to the nutrition assistance programs to help ensure the 
best practical outcomes for beneficiaries and the taxpayer.
Major Regulatory Priorities
 This document represents summary information on prospective 
significant regulations as called for in Executive Order 12866. The 
following agencies are represented in this regulatory plan, along with 
a summary of their mission and key regulatory priorities for 2005:
Food and Nutrition Service
 Mission: FNS increases food security and reduces hunger in partnership 
with cooperating organizations by providing children and low-income 
people access to food, a healthful diet, and nutrition education in a 
manner that supports American agriculture and inspires public 
confidence.
 Priorities: In addition to responding to provisions of legislation 
authorizing and modifying Federal nutrition assistance programs, FNS' 
2004 regulatory plan supports the broad goals and objectives in the 
Agency's strategic plan that include:

[[Page 72664]]

Improved
 Nutrition of Children and Low-Income People. This goal represents FNS' 
efforts to improve nutrition by providing access to program benefits 
(Food Stamps, WIC food vouchers and nutrition services, school meals, 
commodities, and State administrative funds), nutrition education, and 
quality meals and other benefits. It includes three major objectives: 
1) Improved food security, which reflects nutrition assistance benefits 
issued to program participants; 2) FNS program participants make 
healthy food choices, which represents our efforts to improve nutrition 
knowledge and behavior through nutrition education and breastfeeding 
promotion; and 3) improved nutritional quality of meals, food packages, 
commodities, and other program benefits, which represents our efforts 
to ensure that program benefits meet the appropriate nutrition 
standards to effectively improve nutrition for program participants.
In support of this goal, FNS plans to finalize rules implementing 
provisions of the Farm Security and Rural Investment Act of 2002 (Pub. 
L. 107-171), as well as under other authorities, that will give States 
additional new flexibility to streamline complex rules, simplify 
program administration, support work, and improve access to benefits in 
the Food Stamp Program. FNS will also publish rules implementing 
provisions of the Child Nutrition and WIC Reauthorization Act of 2004 
(Pub. L. 108-265) to improve access to the WIC and Child Nutrition 
Programs and to support and strengthen school and community-based 
efforts to promote healthful eating and physical activity.
Improved
 Stewardship of Federal Funds. This goal represents FNS' ongoing 
commitment to maximize the accuracy of benefits issued, maximize the 
efficiency and effectiveness of program operations, and minimize 
participant and vendor fraud. It includes two major objectives: 1) 
Improved benefit accuracy and reduced fraud, which represents the 
Agency's effort to reduce participant and Agency errors and to control 
Food Stamp and WIC trafficking and participant, vendor, and 
administrative agency fraud; and 2) improved efficiency of program 
administration, which represents our efforts to streamline program 
operations and improve program structures as necessary to maximize 
their effectiveness.
In support of this goal, FNS plans to finalize rules implementing 
provisions of Public Law 107-171 that give States substantial new 
flexibility to streamline some of the Food Stamp Program's complex 
rules, making it easier to administer and less error-prone. In 
addition, FNS will finalize rules that will simplify funding for the 
Food Stamp Employment and Training Program, and propose rules to 
enhance retailer sanctions and to streamline the sanction process. FNS 
will also publish rules implementing provisions of the Child Nutrition 
and WIC Reauthorization Act of 2004 (Pub. L. 108-265) to promote the 
accuracy of the certification process in the school meals programs, to 
improve WIC vendor management, and to ensure the effectiveness of WIC 
infant formula rebates in reducing program costs.
Food Safety and Inspection Service
 Mission: The Food Safety and Inspection Service (FSIS) is responsible 
for ensuring that meat, poultry, and egg products in commerce are 
wholesome, not adulterated, and properly marked, labeled, and packaged.
 Priorities: FSIS is committed to developing and issuing science-based 
regulations intended to ensure that meat, poultry, and egg products are 
wholesome and not adulterated or misbranded. FSIS continues to review 
its existing authorities and regulations to ensure that emerging food 
safety challenges are adequately addressed, to streamline excessively 
prescriptive regulations, and to revise or remove regulations that are 
inconsistent with the Agency's hazard analysis and critical control 
point regulations.
 In addition to undertaking regulatory amendments based on the results 
of its review activities, FSIS has been developing regulations for 
emergency use. Such regulations are an outcome of the Agency's 
proactive, risk-based policy toward emerging and exotic threats to the 
safety of the Nation's meat, poultry, and egg product supply.
 Following are some of the Agency's recent and planned initiatives:
 In February 2001, FSIS proposed a rule to establish food safety 
performance standards for all processed ready-to-eat (RTE) meat and 
poultry products and for partially heat-treated meat and poultry 
products that are not ready-to-eat. The proposal contained provisions 
addressing post-lethality contamination of RTE products with Listeria 
monocytogenes. In June 2003, FSIS published an interim final rule 
requiring establishments that produce RTE products to apply verified 
control measures to prevent such product contamination. The Agency is 
planning further action with respect to other elements of the 2001 
proposal.
 In January 2004, FSIS issued a series of interim final rules to 
prevent the bovine spongiform encephalopathy (BSE) agent from entering 
the human food supply. FSIS issued the interim final rules in response 
to the confirmation of BSE in an imported cow in Washington State. The 
cow was imported from Alberta, Canada. The interim final rules: 1) 
Prohibit material that scientific studies demonstrate contain the BSE 
agent in cattle infected with BSE for use as human food; 2) prohibit 
the slaughter of non-ambulatory disabled cattle for human food; 3) 
prohibit the use of air-injection stunning devices on cattle; and 4) 
establish additional requirements for beef meat produced using advanced 
meat recovery (AMR) systems to ensure that high risk tissues are not 
incorporated into beef AMR product. In addition, in January 2004, FSIS 
issued a Federal Register Notice announcing that it would no longer 
pass and apply the mark of inspection to carcasses selected for BSE 
testing by USDA's Animal and Plant Health Inspection Service (APHIS) 
until the sample is determined to be negative. In July 2004, FSIS, 
APHIS, and the Food and Drug Administration issued an Advance Notice of 
Proposed Rulemaking (ANPRM) to solicit comments on additional actions 
that could be implemented by the U.S. government to prevent animal and 
human exposure to the BSE agent. The comment period for the ANPRM 
closed on September 14, 2004.
 FSIS will propose removing from the poultry products inspection 
regulations the requirement for ready-to-cook poultry products to be 
chilled to 40 [deg]F or below within certain time periods according to 
the weight of the dressed carcasses.
 FSIS has proposed a rule clarifying requirements for meat produced 
using advanced recovery systems by replacing the compliance program 
parameters in the current regulations with non-compliance criteria for 
bone solids, bone marrow, and neural tissue. Establishments would have 
to have process control procedures in place before labeling or using 
the product derived by use of such systems.
 In addition, FSIS is planning to propose requirements for federally 
inspected egg product plants to develop and implement HACCP systems and

[[Page 72665]]

sanitation standard operating procedures. The Agency will be proposing 
pathogen reduction performance standards for egg products. Further, the 
Agency will be proposing to remove requirements for approval by FSIS of 
egg-product plant drawings, specifications, and equipment prior to use, 
and to end the system for pre-marketing approval of labels for egg 
products.
 FSIS will also propose to remove provisions that prescribe the 
substances and amounts of such substances that must be used to produce 
pumped or massaged bacon. FSIS will propose to replace these 
prescriptive provisions with an upper limit for nitrite and a 
performance standard that establishments producing pumped or massaged 
bacon would be required to meet.
 FSIS has proposed requirements for the nutrition labeling of ground or 
chopped meat and poultry products and single-ingredient products. This 
proposed rule would require nutrition labeling, on the label or at the 
point-of-purchase, for the major cuts of single-ingredient, raw 
products and would require nutrition information on the label of ground 
or chopped products.
 In addition, FSIS is developing a proposed rule with the Food and Drug 
Administration (FDA). FSIS and FDA are proposing to establish a set of 
general principles for food standards. The proposed general principles 
will establish the criteria that the agencies will use in considering 
whether a petition to establish, revise, or eliminate a food standard 
will be the basis for a proposed rule. These proposed general 
principles are the agencies' first step in instituting a process to 
modernize their standards of identity (and any accompanying standards 
of quality and fill of container) and standards of composition.
 Small business concerns: Nearly all FSIS regulations affect small 
businesses in some way because the majority of FSIS-inspected 
establishments and other FSIS-regulated entities are small businesses. 
FSIS makes available to small and very small establishments technical 
materials and guidance on how to comply with FSIS regulations. The 
Agency's post-September 11, 2001, security guidance materials were 
prepared especially for the benefit of small firms involved in the 
production, transportation, and distribution of meat, poultry, and egg 
products.
Animal and Plant Health Inspection Service
 Mission: The mission of the Animal and Plant Health Inspection Service 
(APHIS) is to protect the health and value of American agricultural and 
natural resources. APHIS conducts programs to prevent the introduction 
of exotic pests and diseases into the United States and conducts 
surveillance, monitoring, control, and eradication programs for pests 
and diseases in this country. These activities enhance agricultural 
productivity and competitiveness and contribute to the national economy 
and the public health.
 Priorities: APHIS continues to work on regulatory initiatives to 
ensure that a comprehensive framework is in place to address the 
threats posed to animal and plant resources. One important animal 
health initiative is a herd certification program for chronic wasting 
disease, a neurological disease of deer and elk. APHIS is also 
proceeding with rulemaking to improve its provisions for providing 
indemnity for animals and materials should an outbreak of foot-and-
mouth disease occur in the United States. On the plant side, APHIS is 
planning to revise the regulations for the introduction of organisms 
and products altered or produced through genetic engineering to reflect 
new consolidated authorities under the Plant Protection Act. The Agency 
is also considering revisions to its nursery stock regulations to 
reduce the risk posed by imported plants, roots, seeds, bulbs, and 
other propagative materials. APHIS is also continuing to work with the 
Centers for Disease Control and Prevention to implement and amend, as 
necessary, regulations for the possession, use, and transfer of 
biological agents and toxins that could pose a severe disease or pest 
risk to animals and plants or their products.
 In addition, recognizing the need to minimize impediments to trade 
while providing necessary protection to animal and plant resources, 
APHIS is developing a proposal to streamline the process for approving 
new fruits and vegetables for importation. The Agency is also 
continuing to work on amending its regulations concerning bovine 
spongiform encephalopathy (BSE) to provide for the importation of 
certain animals and products that present low risk, particularly from 
countries such as Canada, where effective measures have been in place 
to prevent the spread of the disease.
 APHIS documents published in the Federal Register and related 
information, including the names of organizations and individuals who 
have commented on APHIS dockets, are available on the Internet at 
http://www.aphis.usda.gov/ppd/rad/webrepor.html.
Agricultural Marketing Service
 Mission: The Agricultural Marketing Service (AMS) facilitates the 
marketing of agricultural products in domestic and international 
markets, while ensuring fair trading practices and promoting a 
competitive and efficient marketplace to the benefit of producers, 
traders, and consumers of U.S. food and fiber products.
 Priorities: (1) As mandated by the 2002 Farm Bill, AMS is establishing 
a mandatory country of origin program for beef, lamb, pork, fish, 
perishable agricultural commodities, and peanuts. Under current Federal 
laws and regulations, country of origin labeling is not universally 
required for these commodities. In particular, labeling of U.S. origin 
is not mandatory, and labeling of imported products at the consumer 
level is not required in all cases. Thus, consumers desiring to 
purchase products based on country of origin are not fully able to do 
so. A proposed rule was published October 30, 2003, based on interim 
voluntary guidelines also required by the 2002 Farm Bill (that were 
issued on October 8, 2002), and related input from listening sessions 
held throughout the country during 2003. On October 5, 2004, the 
Agricultural Marketing Service published an interim final rule with 
request for comments for the labeling of fish and shellfish covered 
commodities that will become effective on April 4, 2005. A final 
regulatory action for all covered commodities will be issued by June 
30, 2006.
 (2) On April 12, 2003, Congress amended the Organic Foods Production 
Act (OFPA) to authorize certification of wild seafood. In response to 
this, AMS plans to propose regulations to amend the National Organic 
Program (NOP) regulations to add practice standards for organic 
certification of wild-caught and aquatic farm raised species. Under the 
OFPA, an organic certification program must be established for 
producers and handlers of agricultural products that have been produced 
using organic methods. The NOP has been reviewing organic certification 
of fish including wild-caught and aquaculture operations in response to 
a FY 2000 congressional mandate to develop regulations for the 
certification of seafood. The NOP has engaged in public meetings and 
workshops and conducted public comment proceedings on this subject.

[[Page 72666]]

 AMS Program Rulemaking Pages: All of AMS' rules, as published in the 
Federal Register, are available on the Internet at http://
www.ams.usda.gov/rulemaking. This site also includes commenting 
instructions and addresses, links to news releases and background 
material, and comments received on various rules.
Farm Service Agency
 Mission: The mission of the Farm Service Agency is to stabilize farm 
income, help farmers conserve land and water resources, provide credit 
to new or disadvantaged farmers and ranchers, and help farm operations 
recover from the effects of disaster.
 Priorities: The Farm Service's immediate priorities are to: (1) 
Implement the disaster assistance programs required by the Emergency 
Supplemental Appropriations for Hurricane Disaster Assistance Act, 2005 
(H.R. 4837) and (2) implement the tobacco buyout program required by 
the Fair and Equitable Tobacco Reform Act of 2004 (Pub. L. 108-357). 
The disaster programs will provide assistance to agricultural producers 
in areas that were affected by the unusual number and severity of 
hurricanes in 2003 and 2004 for losses of crops, livestock, trees, 
dairy production, and sugarcane. The tobacco buyout program will end 
the 70-year-old tobacco quota and price support program. Quota holders 
and producers will be compensated for the value of their lost quota 
through a program financed by assessments on manufacturers and 
importers of tobacco products.
Forest Service
 Mission: The mission of the Forest Service is to sustain the health, 
productivity, and diversity of the Nation's forests and rangelands to 
meet the needs of present and future generations. This includes 
protecting and managing National Forest System lands; providing 
technical and financial assistance to States, communities, and private 
forest landowners; and developing and providing scientific and 
technical assistance and scientific exchanges in support of 
international forest and range conservation.
 Priorities: The Forest Service's priorities for fall 2004 are to 
publish final regulations at 36 CFR part 219, subpart A, to establish a 
framework for National Forest System land management planning and to 
seek comments on a proposed rule to replace the existing regulations at 
36 CFR part 294, subpart B, with a petitioning process that would 
provide Governors an opportunity to seek establishment of management 
requirements for National Forest System inventoried roadless areas 
within their State.
 The final planning rule reaffirms an emphasis on sustainability to 
provide for multiple uses over time and reaffirms an adaptive cycle of 
land management planning, including detailed project planning, plan 
implementation, monitoring, evaluation, and plan amendment or revision. 
This final rule is based on the principle that plans provide a 
framework for subsequent detailed project analysis and that analysis 
and disclosure are continuous throughout the adaptive planning cycle. A 
proposed rule was published in the Federal Register on December 6, 2002 
(67 FR 72770).
 The proposed State petitions for inventoried roadless area management 
rule emphasizes a commitment to collaborate and cooperate with States 
on the long-term strategy for the management of inventoried roadless 
areas on National Forest System lands. The petition process allows for 
the recognition of local situations and resolution of unique resource 
management challenges within a specific State. A proposed rule was 
published in the Federal Register on July 16, 2004 (69 FR 42636). The 
comment period originally ended on September 14, 2004, but was extended 
to November 15, 2004 (69 FR 54600).
Natural Resources Conservation Service
 Mission: The Natural Resources Conservation Service (NRCS) mission is 
to provide leadership in a partnership effort to help people conserve, 
maintain, and improve our natural resources and environment.
 Priorities: NRCS' priority for FY 2005 will be to finalize the rules 
related to the conservation provisions of the Farm Security and Rural 
Investment Act of 2002 (the 2002 Farm Bill), in response to public 
comments received pursuant to the promulgation of interim final rules 
for those programs. NRCS believes that these clarifications and 
modifications will ensure efficient and responsive delivery of 
conservation programs to landowners and land users and help further the 
agency mission to help people conserve, maintain, and improve our 
natural resources and the environment.
 A non-Farm Bill priority for NRCS remains updating the 1981 Emergency 
Watershed Protection Program rule. New rulemaking will implement 
necessary efficiencies and make the EWP policies and rule more 
consistent. It will also ensure the Agency quickly meets the needs of 
landowners and sponsors adversely impacted by natural disasters and 
assists these communities in their recovery efforts.
 NRCS remains committed to compliance with the Government Paperwork 
Elimination Act and the Freedom to E-File Act, which require Government 
agencies in general and NRCS in particular to provide the public the 
option of submitting information or transacting business electronically 
to the maximum extent possible. NRCS is designing its program forms to 
allow the public to conduct business with NRCS electronically.
 The NRCS plans to publish the following proposed or final rules during 
FY 2005:
1. Final Rule for the Technical Service Provider Assistance (TSP)
2. Final Rule for the Conservation Security Program (CSP)
3. Final Rule for Grassland Reserve Program (GRP)
4. Interim Final Rule for Confidentiality to provide the regulatory 
            framework for existing statutory mandate and NRCS policy 
            guidance.
5. Final Rule for the Emergency Watersheds Program (EWP)
 The rulemaking for CSP, TSP, GRP, EWP, CIG, and Appeals are minor 
changes to existing interim final rules, and efforts will focus on 
making these rules final.
_______________________________________________________________________

USDA--Agricultural Marketing Service (AMS)

                              -----------

                             PRERULE STAGE

                              -----------




1. NATIONAL ORGANIC PROGRAM: ADD STANDARDS FOR THE ORGANIC 
CERTIFICATION OF WILD CAPTURED AQUATIC ANIMALS (TM-01-08)
Priority:


Other Significant


Legal Authority:


7 USC 6501 through 6522


CFR Citation:


7 CFR 205


Legal Deadline:


None

[[Page 72667]]

Abstract:


The Agricultural Marketing Service (AMS) is revising regulations 
pertaining to labeling of agricultural products as organically produced 
and handled (7 CFR part 205). The term ``aquatic animal'' will be 
incorporated in the definition of livestock to establish production and 
handling standards for operations that capture aquatic animals from the 
wild. AMS has defined ``aquatic animal'' as any finfish or shellfish 
used for human consumption, whether taken from regulated but free 
roaming marine and fresh water populations (wild captured) or 
propagated and raised in a controlled or selected environment 
(aquaculture). Production standards for operations producing aquatic 
animals will incorporate requirements for livestock origin, feed 
ration, health care, living conditions, and recordkeeping. Handling 
standards for such operations will address prevention of commingling of 
organically produced commodities and prevention of contact between 
organically produced and prohibited substances.


Statement of Need:


This amendment to the National Organic Program is intended to 
facilitate interstate commerce and marketing of fresh and processed 
aquatic animals that are organically produced and to assure consumers 
that such products meet consistent, uniform standards. Also, this 
amendment will establish national standards for the production and 
handling of organically-produced aquatic animals and products, 
including a national list of substances approved and prohibited for use 
in organic production and handling.


Summary of Legal Basis:


This amendment is proposed under the Organic Foods Production Act of 
1990 (OFPA). OFPA includes fish for food in its definition of 
livestock. Additionally, on April 12, 2003, Congress amended OFPA 
section 2107 (7 U.S.C. 6506) to authorize certification of wild 
seafood.


Alternatives:


AMS is fulfilling a congressional mandate to proceed with rulemaking 
for the establishment of national standards for the organic production 
and handling of aquatic animals.


Other options are to do nothing or to propose regulations prohibiting 
the labeling of aquatic animals as organically produced. Neither 
alternative is viable inasmuch as Congress has amended OFPA to 
authorize certification of wild seafood and is expecting the USDA to 
engage in rulemaking to establish standards for the production, 
handling, and labeling of organic aquatic animals.


Anticipated Cost and Benefits:


Potential benefits to consumers include more information on organic 
aquatic animals and protection from false and misleading organic 
claims. This proposal will address the problem of existing certifying 
agents using different standards. This proposal will also resolve the 
issue of whether aquatic animals can be labeled as organically 
produced.


The costs of this proposed regulation are the direct costs to comply 
with the specific standards. USDA-accredited certifying agents 
potentially will incur additional costs of accreditation should they 
opt to certify producers and handlers of aquatic animals. New 
applicants for accreditation to certify producers and handlers of 
aquatic animals under the National Organic Program will incur fees for 
accreditation. Producers and handlers of organically produced and 
handled aquatic animals will incur costs for certification levied by 
USDA-accredited certifying agents. USDA would not levy any fees on the 
certified operations. Producers and handlers will face numerous 
provisions that will regulate their production and handling methods. 
Retailers would not be directly regulated but would be subject to the 
same requirements for organic animals and products as they are 
currently for other foods under the NOP. AMS believes this action will 
have a minimal impact on retailers. Certified handlers will have to 
comply with requirements regarding the approved use of labels. The 
USDA, States operating State programs, and certifying agents will incur 
costs for enforcement of these new organic standards. Certifying 
agents, producers, and handlers would incur costs for reporting and 
recordkeeping. Certifying agents will be required to file reports and 
documents with the USDA and to maintain records regarding their 
accreditation and the certification of their clients. Certified 
operations will be required to develop and annually update an organic 
system plan and to maintain records regarding their certification and 
the administration of their operation.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM                                                          12/00/04
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Governmental Jurisdictions


Government Levels Affected:


Federal, Local, State, Tribal


Agency Contact:
Richard H. Mathews
Associate Deputy Administrator
Department of Agriculture
Agricultural Marketing Service
Rm. 2510-South
14th & Independence Avenue SW
Washington, DC 20250
Phone: 202 720-3252
Fax: 202 205-7808
Email: [email protected]
RIN: 0581-AB97
_______________________________________________________________________

USDA--AMS

                              -----------

                            FINAL RULE STAGE

                              -----------




2. MANDATORY COUNTRY OF ORIGIN LABELING OF BEEF, PORK, LAMB, FISH, 
PERISHABLE AGRICULTURAL COMMODITIES, AND PEANUTS (LS-03-04)
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


7 USC 1621 through 1627, Agricultural Marketing Act of 1946


CFR Citation:


7 CFR 60


Legal Deadline:


Final, Statutory, September 30, 2004.


Abstract:


The Farm Security and Rural Investment Act of 2002 (Farm Bill) (Pub. L. 
107-171) and the 2002 Supplemental Appropriations Act (2002 
Appropriations) (Pub. L. 107-206) amended the Agricultural Marketing 
Act of 1946 (Act) (7 U.S.C. 1621 et seq.) to require retailers to 
notify their customers of the country of origin of covered commodities 
beginning September 30, 2004. Covered commodities include muscle cuts 
of

[[Page 72668]]

beef (including veal), lamb, and pork; ground beef, ground lamb, and 
ground pork; farm-raised fish and shellfish; wild fish and shellfish; 
perishable agricultural commodities; and peanuts. The FY 2004 
Consolidated Appropriations bill (2004 Appropriations) (Pub. L. 108-
199) delayed the implementation of mandatory COOL for all covered 
commodities except wild and farm-raised fish and shellfish until 
September 30, 2006. This final rule contains definitions, the 
requirements for consumer notification and product marking, and the 
recordkeeping responsibilities of both retailers and suppliers.


Statement of Need:


Under current Federal laws and regulations, country of origin labeling 
is not universally required for the covered commodities. In particular, 
labeling of U.S. origin is not mandatory, and labeling of imported 
products at the consumer level is required only in certain 
circumstances. This intent of the law is to provide consumers with 
additional information on which to base their purchasing decisions.


Summary of Legal Basis:


Section 10816 of Public Law 107-171 amended the Agricultural Marketing 
Act of 1946 to require retailers to inform consumers of the country of 
origin for covered commodities beginning September 30, 2004, and 
requires USDA to promulgate requirements for the mandatory labeling 
program no later than September 30, 2004.


Alternatives:


Various methods are being considered by which the objectives of this 
law could be accomplished. The proposed rule specifically invites 
comment on several alternatives including alternative definitions for 
``processed food item,'' alternative labeling of mixed origin, and 
alternatives to using ``slaughtered'' on the label. The proposed rule 
published October 30, 2003, provided for a 60-day comment period which 
closed on December 29, 2003. A notice extending the comment period was 
published December 22, 2003. The notice extended the comment period to 
February 27, 2004.


Anticipated Cost and Benefits:


USDA has examined the economic impact of the proposed rule as required 
by Executive Order 12866. The estimated benefits associated with this 
rule are likely to be negligible. The estimated first-year incremental 
cost for growers, producers, processors, wholesalers, and retailers 
ranges from $582 million to $3.9 billion. The estimated cost to the 
U.S. economy in higher food prices and reduced food production in the 
tenth year after implementation of the rule ranges from $138 million to 
$596 million. AMS has invited further comment on start up costs and 
maintenance costs for the first year and beyond for firms directly 
affected by the proposed rule.


Risks:


AMS has not identified any risks at this time.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            68 FR 61944                                    10/30/03
NPRM Comment Period End                                        12/29/03
Interim Final Ru69 FR 59708                                    10/05/04
Interim Final Rule Comment Period End                          01/03/05
Interim Final Rule Effective                                   04/04/05
Final Action                                                   06/00/06
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


State


Federalism:


This action may have federalism implications as defined in EO 13132.


Additional Information:


The U.S. Department of Agriculture issued an interim final rule with 
request for comments for the labeling of fish and shellfish covered 
commodities that will become effective on April 4, 2005. A final 
regulatory action for all covered commodities will be issued by June 
30, 2006.


Agency Contact:
William Sessions
Associate Deputy Administrator
Department of Agriculture
Agricultural Marketing Service
Room 2092-South, Stop 0249
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 720-5705
Email: [email protected]
RIN: 0581-AC26
_______________________________________________________________________

USDA--Animal and Plant Health Inspection Service (APHIS)

                              -----------

                             PRERULE STAGE

                              -----------




3. REVISION OF THE NURSERY STOCK REGULATIONS (Q.37)
Priority:


Other Significant


Legal Authority:


7 USC 450; 7 USC 7701 to 7772; 21 USC 136 to 136a


CFR Citation:


7 CFR 319


Legal Deadline:


None


Abstract:


This action will solicit public comment on whether and how we should 
amend the regulations that govern the importation of nursery stock, 
also known as plants for planting. Under the current regulations, all 
plants for planting are allowed to enter the United States if they are 
accompanied by a phytosanitary certificate and if they are inspected 
and found to be free of plant pests, unless their importation is 
specifically prohibited or further restricted by the regulations. We 
are considering several possible changes to this approach, including 
establishing a category in the regulations for plants for planting that 
would be excluded from importation pending risk evaluation and 
approval; developing ongoing programs to reduce the risk of entry and 
establishment of quarantine pests via imported plants for planting; 
combining existing regulations governing the importation of plants for 
planting into one subpart; and reevaluating the risks posed by 
importation of plants for planting whose importation is currently 
prohibited. We are also considering how to best collect data on current 
imports of plants for planting so we can accurately ascertain the 
volume, type, and origin of such plants entering the United States. We 
are soliciting public comment on these issues to help us determine what 
changes we should propose to improve our regulations and which of these 
changes should be assigned the highest priority for implementation.


Statement of Need:


APHIS typically relies on inspection at a Federal plant inspection 
station or

[[Page 72669]]

port of entry to mitigate the risks of pest introduction associated 
with the importation of plants for planting. Importation of plants for 
planting is further restricted or prohibited only if there is specific 
evidence that such importation could introduce a quarantine pest into 
the United States. Most of the taxa of plants for planting currently 
being imported have not been thoroughly studied to determine whether 
their importation presents a risk of introducing a quarantined pest 
into the United States. The volume and the number of types of plants 
for planting have increased dramatically in recent years, and there are 
several problems associated with gathering data on what plants for 
planting are being imported and on the risks such importation presents. 
In addition, quarantined pests that enter the United States via the 
importation of plants for planting pose a particularly high risk of 
becoming established within the United States. Given these 
circumstances, APHIS needs to consider various ways in which the 
regulations governing plants for planting might be revised in order to 
address the risk of pest introduction via the importation of plants for 
planting. This ANPRM solicits public comment on several measures we are 
considering.


Summary of Legal Basis:


The Secretary of Agriculture may prohibit or restrict the importation 
or entry of any plant if the Secretary determines that the prohibition 
or restriction is necessary to prevent the introduction into the United 
States of a plant pest or noxious weed (7 U.S.C. 7712).


Alternatives:


APHIS has identified two alternatives to the approach we are 
considering in this advance notice of proposed rulemaking. The first is 
to maintain the status quo; this alternative was rejected because, 
given our limited resources and the risks of pest introduction posed by 
the rapid increase in the importation of plants for planting, we do not 
believe that this approach would allow us to address the potential 
risks posed by quarantine pests in a timely manner. The second is to 
prohibit the importation of all nursery stock pending risk evaluation, 
approval, and notice-and-comment rulemaking, similar to APHIS's 
approach to regulating imported fruits and vegetables; this approach 
was rejected because, in the absence of additional resources for 
conducting risk evaluation and rulemaking, this approach would lead to 
a major interruption in international trade and would have significant 
economic effects on both U.S. importers and U.S. consumers of plants 
for planting.


Anticipated Cost and Benefits:


This action is currently in the advance notice of proposed rulemaking 
stage; we are gathering information to guide us in deciding what 
actions to take. In the absence of specific proposed measures, we 
cannot determine specific costs and benefits. However, the costs 
associated with plant pests that are introduced to the United States 
via imported nursery stock are expected to increase in the absence of 
some action to revise the nursery stock regulations to allow us to 
better address pest risks.


Risks:


In the absence of some action to revise the nursery stock regulations 
to allow us to better address pest risks, increased introductions of 
plant pests via imported nursery stock are likely, causing extensive 
damage to both agricultural and natural plant resources.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM                                                          12/00/04
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None


Additional Information:


APHIS documents published in the Federal Register and related 
information, including the names of organizations and individuals who 
have commented on APHIS dockets, are available on the Internet at 
http://www.aphis.usda.gov/ppd/rad/webrepor.html.


Agency Contact:
Dr. Arnold T. Tschanz
Senior Staff Officer, Regulatory Coordination Staff, PPQ
Department of Agriculture
Animal and Plant Health Inspection Service
Unit 141
4700 River Road
Riverdale, MD 20737-1236
Phone: 301 734-5306
RIN: 0579-AB85
_______________________________________________________________________

USDA--APHIS

                              -----------

                            FINAL RULE STAGE

                              -----------




4. FOOT-AND-MOUTH DISEASE; PAYMENT OF INDEMNITY
Priority:


Other Significant


Legal Authority:


7 USC 8301 to 8317


CFR Citation:


9 CFR 53


Legal Deadline:


None


Abstract:


This rule would amend the regulations for the cooperative control and 
eradication of foot-and-mouth disease (FMD) and other serious diseases, 
including both cooperative programs and extraordinary emergencies. The 
purpose of this rule is to remove possible sources of delay in 
eradicating foot-and-mouth disease, should an occurrence of that 
disease occur in this country, so that eligible claimants will be fully 
compensated while at the same time protecting the U.S. livestock 
population from the further spread of this highly contagious disease.


Statement of Need:


APHIS has reviewed these regulations to determine their sufficiency, 
should an occurrence of foot-and-mouth disease occur in the United 
States. This review was prompted, in part, by a series of outbreaks of 
foot-and-mouth disease that occurred in the United Kingdom and 
elsewhere around the world. Based on this review, APHIS has determined 
that changes to the regulations are needed with regard to the valuation 
of animals and materials, as well as the payment of an indemnity to 
those persons who suffer loss of property as a result of foot-and-mouth 
disease.


Summary of Legal Basis:


The Secretary of Agriculture, either independently or in cooperation 
with other Federal agencies, States or political subdivisions of 
States, national governments of foreign countries, local governments of 
foreign countries, domestic or international organizations, domestic or 
international associations, Indian tribes, and other persons, may carry 
out operations and measures to detect, control, or eradicate any pest 
or

[[Page 72670]]

disease of livestock that threatens the livestock of the United States, 
including the payment of claims arising out of the destruction of any 
animal, article, or means of conveyance, if necessary to prevent the 
dissemination of the pest or disease of livestock (7 U.S.C. 8306, 8308, 
8310, and 8315).


Alternatives:


The rule comprises several regulatory changes, each of which is 
intended to facilitate the control and eradication of foot-and-mouth 
disease, should an outbreak of this disease occur in the United States. 
Reasonable alternatives to the rule would be to not make any changes at 
all and rely on the current regulations as applied to cooperative 
programs and extraordinary emergencies.


Anticipated Cost and Benefits:


The rule is expected to affect livestock operations and Federal and 
State government agencies. The vast majority of livestock operations 
are small entities. The potential costs and benefits would depend upon 
the characteristics of the outbreak and mitigation strategy. The 
proposed changes would strengthen programs for the control and 
eradication of FMD by broadening USDA's options. The changes would also 
lessen the chances that FMD's eradication would be delayed.


Risks:


The changes contained in the rule would be particularly important in 
removing sources of delay in achieving FMD eradication, should an 
outbreak of foot-and-mouth disease occur in the United States. An 
effective response in the early stages of such an outbreak greatly 
reduces the risk of the disease's wider dissemination.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            67 FR 21934                                    05/01/02
NPRM Comment Per67 FR 43566d                                   06/28/02
NPRM Comment Period End                                        07/01/02
NPRM Comment Period End                                        07/31/02
Final Action                                                   06/00/05
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Federal, State


Additional Information:


APHIS documents published in the Federal Register and related 
information, including the names of organizations and individuals who 
have commented on APHIS dockets, are available on the Internet at 
http://www.aphis.usda.gov/ppd/rad/webrepor.html.


Agency Contact:
Dr. Mark Teachman
Senior Staff Veterinarian, Emergency Programs, VS
Department of Agriculture
Animal and Plant Health Inspection Service
Unit 41
4700 River Road
Riverdale, MD 20737-1231
Phone: 301 734-8073
RIN: 0579-AB34
_______________________________________________________________________

USDA--APHIS



5. CHRONIC WASTING DISEASE IN ELK AND DEER; INTERSTATE MOVEMENT 
RESTRICTIONS AND PAYMENT OF INDEMNITY
Priority:


Other Significant


Legal Authority:


7 USC 8301 to 8316


CFR Citation:


9 CFR 55; 9 CFR 81


Legal Deadline:


None


Abstract:


This rulemaking would establish requirements for the interstate 
movement of farmed elk and deer and provide indemnity for the 
depopulation of farmed elk and deer that have been infected with, or 
exposed to, chronic wasting disease (CWD).


Statement of Need:


CWD has been confirmed in free-ranging deer and elk in a limited number 
of counties in northeastern Colorado and southeastern Wyoming and has 
also been diagnosed in farmed elk herds in South Dakota, Nebraska, 
Oklahoma, Montana, and Colorado. This project includes an interim rule 
to establish indemnity for voluntary depopulation of CWD-affected 
herds, followed by rulemaking to establish a voluntary certification 
program and interstate movement restrictions on captive elk and deer. 
APHIS believes that establishing restrictions on the interstate 
movement of infected and exposed farmed elk and deer, coupled with the 
payment of some level of indemnity for infected and exposed animals, 
will encourage producers who are not yet engaging in surveillance 
activities to begin doing so. To date, the level of support from States 
and the farmed cervid industry for such a program has been high. 
Without a Federal program in place to depopulate infected and exposed 
animals, the movement of infected animals into new herds and States 
with no known infection will continue or may even accelerate. APHIS 
needs to take action to document the prevalence of the disease and to 
prevent its further spread.


Summary of Legal Basis:


The Secretary of Agriculture, either independently or in cooperation 
with other Federal agencies, States or political subdivisions of 
States, national governments of foreign countries, local governments of 
foreign countries, domestic or international organizations, domestic or 
international associations, Indian tribes, and other persons, may carry 
out operations and measures to detect, control, or eradicate any pest 
or disease of livestock of the United States, including the payment of 
claims arising out of the destruction of any animal, article, or means 
of conveyance, if necessary to prevent the dissemination of the pest or 
disease of livestock (7 U.S.C. 8305 to 8306, 8308, 8310, and 8315).


Alternatives:


APHIS has identified two additional alternatives to our selected 
action. The first--to maintain the status quo--was rejected because it 
would not address the animal disease risks associated with CWD. The 
second option would have been to provide financial and technical 
assistance to the cervid industry for continuation and expansion of a 
variety of herd management practices to reduce or eliminate CWD. 
Although this option may be less costly than the option chosen by 
APHIS, this option was not selected because it would not advance CWD 
eradication as quickly or effectively as the chosen option. However, 
APHIS will continue to work with industry to develop voluntary herd 
management practices to preserve and increase the reduction in CWD 
levels that the proposed program is expected to achieve.


Anticipated Cost and Benefits:


The presence of CWD in elk and deer causes significant economic and 
market

[[Page 72671]]

losses to U.S. producers. Recently, Canada has begun to require, as a 
condition for importing U.S. elk into Canada, that the animals be 
accompanied by a certificate stating that the herd of origin is not 
located in Colorado or Wyoming, and CWD has never been diagnosed in the 
herd of origin. The Republic of Korea recently suspended the 
importation of deer and elk and their products from the United States 
and Canada. Fear of CWD can severely affect the domestic prices for 
deer and elk, as it is more difficult for producers to sell cervid that 
are associated with any hint of exposure to the disease.


Risks:


Aggressive action in controlling this disease now will decrease the 
chance of having to deal with a much larger, widespread, and costly 
problem later, such as the situation with bovine spongiform 
encephalopathy (``mad cow disease'') in Europe. Although there is 
currently no evidence that CWD is linked to disease in humans, or in 
domestic animals other than deer and elk, a theoretical risk of such a 
link exists.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Interim Final Ru67 FR 5925                                     02/08/02
Interim Final Rule Comment Period End                          04/09/02
NPRM            68 FR 74513                                    12/24/03
NPRM Comment Period End                                        02/23/04
Final Action                                                   03/00/05
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


Federal, State


Additional Information:


APHIS documents published in the Federal Register and related 
information, including the names of organizations and individuals who 
have commented on APHIS dockets, are available on the Internet at 
http://www.aphis.usda.gov/ppd/rad/webrepor.html.


Agency Contact:
Dr. Dean Goeldner
Staff Veterinarian, National Center for Animal Health Programs
Department of Agriculture
Animal and Plant Health Inspection Service
4700 River Road
Unit 43
Riverdale, MD 20737-1231
Phone: 301 736-4916
RIN: 0579-AB35
_______________________________________________________________________

USDA--Food and Nutrition Service (FNS)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




6. SENIOR FARMERS' MARKET NUTRITION PROGRAM (SFMNP)
Priority:


Other Significant


Legal Authority:


PL 107-171, sec 4306


CFR Citation:


7 CFR 249


Legal Deadline:


None


Abstract:


This proposed rule will implement the provision of the Farm Security 
and Rural Investment Act of 2002 (Pub. L. 107-171) that gives the 
Department the authority to promulgate regulations for the operation 
and administration of the SFMNP. The purposes of the SFMNP are to 
provide fresh, nutritious, unprepared locally grown fruits, vegetables, 
and herbs from farmers' markets, roadside stands, and community 
supported agriculture programs to low-income seniors and to increase 
the consumption of agricultural commodities by expanding, developing, 
and/or aiding in the development of domestic farmers' markets, roadside 
stands, and community supported agriculture programs. (02-012)


Statement of Need:


The SFMNP has been administered since fiscal year 2001 as a competitive 
grant program in which State agencies, interested in receiving a grant 
to operate the program, submitted an application for SFMNP grant funds 
to USDA's Food and Nutrition Service. Such grants were reviewed and 
ranked against a set of explicit criteria, and SFMNP grants were then 
awarded to those State agencies whose applications received the highest 
scores. Public Law 107-171 authorized funding for the SFMNP through FY 
2007 and also gave the Department the authority to promulgate 
regulations for the future operation and administration of the SFMNP. 
This legislative action establishes the SFMNP as a permanent nutrition 
assistance program and eliminates the need for State agencies to 
participate in an annual competition for program funds. Therefore, this 
proposed rulemaking converts the SFMNP from a competitive grant program 
to a permanent FNS-administered nutrition assistance program.


Summary of Legal Basis:


Public Law 107-171 (section 4306) authorized funding for the SFMNP 
through FY 2007 and also gave the Department the authority to 
promulgate regulations for the future operation and administration of 
the SFMNP.


Alternatives:


USDA considered a variety of alternatives when constructing the 
regulation for the SFMNP. Primarily, the proposed regulation is modeled 
after the WIC Farmers' Market Nutrition Program and the Senior Farmers' 
Market Nutrition Pilot Programs. Consistency lends to administrative 
ease among the State agencies, localities, and USDA, as well as 
provides continuity to beneficiaries and farmers who have been 
operating the pilot programs since 2001. Nevertheless, USDA addressed 
seven specific alternatives: Type of grant structure, eligible grantees 
and recipients, the use of community-supported agriculture programs, 
provision of administrative funding, eligibility requirements, 
verification procedures, and benefit levels. Each of these alternatives 
is explored in detail in the preamble to the proposed rulemaking.


Anticipated Cost and Benefits:


The funding level for the SFMNP is expected to remain stable through FY 
2007. Therefore, the Department does not anticipate significant changes 
to the costs/benefits of the SFMNP as a result of the publication of 
this proposed rule.


Risks:


The proposed rule carries a 90-day comment period, during which 
interested parties may submit comments on any and all provisions 
contained in the rulemaking. Once the

[[Page 72672]]

comment period has expired, all comments received will be carefully 
considered in the development of the final rule. Opportunities for 
training on and discussion of the SFMNP regulations (in both their 
proposed and final forms) will be offered to State agencies and other 
entities with a vested interest in the operation and administration of 
the SFMNP.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           02/00/05
NPRM Comment Period End                                        05/00/05
Final Action                                                   09/00/05
Final Action Effective                                         10/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses, Organizations


Government Levels Affected:


Federal, Local, State, Tribal


Federalism:


Undetermined


URL For More Information:
www.fns.usda.gov
URL For Public Comments:
www.fns.usda.gov/wic
Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 918
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
RIN: 0584-AD35
_______________________________________________________________________

USDA--FNS



7. FSP: DISCRETIONARY QUALITY CONTROL PROVISIONS OF TITLE IV OF PUBLIC 
LAW 107-171
Priority:


Other Significant


Legal Authority:


7 USC 2011 to 2032; PL 107-171


CFR Citation:


7 CFR 271; 7 CFR 273; 7 CFR 275; 7 CFR 277


Legal Deadline:


None


Abstract:


This proposed rule will implement several quality control changes to 
the Food Stamp Act required by sections 4118 and 4119 of title IV of 
the Farm Security and Rural Investment Act of 2002 (Pub. L. 107-171). 
The provisions in this rule affect the following areas: 1) The 
elimination of enhanced funding; 2) revisions to the time frames for 
completing individual case reviews; 3) extending the time frames in the 
procedures for households that refuse to cooperate with QC reviews; 4) 
procedures for adjusting liability determinations following appeal 
decisions; and 5) conforming and technical changes. (02-015)


Statement of Need:


The rule is needed to implement several food stamp quality control 
provisions of Public Law 107-171 the Farm Security and Rural Investment 
Act of 2002. Elimination of enhanced funding is required by the Act. 
The Act also requires the Department to propose rules for adjusting 
liability determinations following appeals decisions. The remaining 
changes are either conforming changes resulting from the required 
changes or policy changes already in effect but not updated in the 
regulations.


Summary of Legal Basis:


The legal basis for this rule is Public Law 107-171 the Farm Security 
and Rural Investment Act of 2002.


Alternatives:


This rule deals in part with changes required by title IV of Public Law 
107-171 the Farm Security and Rural Investment Act of 2002. The 
Department has no discretion in eliminating enhanced funding for fiscal 
years 2003 and beyond. The provision addressing results of appeals is 
required to be regulated by Public Law 107-171. The remaining changes 
amend existing regulations and are required to make technical changes 
resulting from these changes or to update policy consistent with 
current requirements.


Anticipated Cost and Benefits:


The provisions of this rule are not anticipated to have any impact on 
benefit levels. The provisions of this rule are anticipated to reduce 
administrative costs.


Risks:


The FSP provides nutrition assistance to millions of Americans 
nationwide. The quality control system measures the accuracy of States 
providing food stamp benefits to the program recipients. This rule is 
intended to implement some of the quality control provisions of title 
IV of Public Law 107-171 the Farm Security and Rural Investment Act of 
2002. The provisions of this rule will eliminate enhanced funding for 
low payment error rates. It will revise the system for determining 
State agency liabilities and sanctions for high payment error rates 
following appeal decisions.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           02/00/05
NPRM Comment Period Ends                                       05/00/05
Final Action                                                   05/00/06
Final Action Effective                                         06/00/06
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, Local, State


Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 918
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
Related RIN: Split from 0584-AD31
RIN: 0584-AD37
_______________________________________________________________________

USDA--FNS



8.  SPECIAL NUTRITION PROGRAMS: FLUID MILK SUBSTITUTIONS
Priority:


Other Significant


Legal Authority:


PL 108-265, sec 102


CFR Citation:


7 CFR 210; 7 CFR 220


Legal Deadline:


None


Abstract:


Currently, by regulation, schools must make substitutions for fluid 
milk for students with a disability when the

[[Page 72673]]

request is authorized by a licensed physician and may make 
substitutions for students with medical or other dietary needs if 
requested by recognized medical authority. These regulatory provisions 
were included in Public Law 108-265 which amended the Richard B. 
Russell National School Lunch Act. Public Law 108-265 also amended the 
current law to allow schools to substitute non-dairy beverages 
nutritionally equivalent (as established by the Secretary) to fluid 
milk for medical or other special dietary needs at the request of a 
parent/guardian. In response to Public Law 108-265, the National School 
Lunch Program and School Breakfast Program regulations will be revised 
to add these requirements.


(04-016)


Statement of Need:


The changes made to the Richard B. Russell National School Lunch Act 
concerning substitutions for fluid milk are intended to assist children 
with an intolerance to or a cultural or other restriction concerning 
the consumption of milk. This regulation allows schools to make 
substitutions at the request of a parent or guardian which assists 
families that are unable to obtain a doctor's statement. However, the 
Secretary must develop criteria to limit the substitutions for milk to 
nutritionally equivalent beverages. The determination of nutritionally 
equivalent beverages will require careful research and consultation.


Summary of Legal Basis:


These changes are being made in response to provisions in Public Law 
108-265.


Alternatives:


USDA will be working with other Federal agencies to develop criteria 
for nutritionally equivalent substitutes for fluid milk as well as 
conducting research. USDA is issuing a proposed rule on this provision 
in order to solicit public comments prior to any final decisionmaking.


Anticipated Cost and Benefits:


Schools may incur additional costs in obtaining and offering substitute 
beverages. However, a significant benefit is to children who cannot 
consume milk and who will now have a nutritionally equivalent beverage 
to milk.


Risks:


USDA must be diligent in making any determinations of nutritional 
equivalency to milk.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           10/00/05
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses, Governmental Jurisdictions


Government Levels Affected:


Local, State


Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 918
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
RIN: 0584-AD58
_______________________________________________________________________

USDA--FNS

                              -----------

                            FINAL RULE STAGE

                              -----------




9. CHILD AND ADULT CARE FOOD PROGRAM: IMPROVING MANAGEMENT AND PROGRAM 
INTEGRITY
Priority:


Other Significant


Legal Authority:


42 USC 1766; PL 103-448; PL 104-193; PL 105-336


CFR Citation:


7 CFR 226


Legal Deadline:


None


Abstract:


This rule amends the Child and Adult Care Food Program (CACFP) 
regulations. The changes in this rule result from the findings of State 
and Federal program reviews and from audits and investigations 
conducted by the Office of Inspector General. This rule revises: State 
agency criteria for approving and renewing institution applications; 
program training and other operating requirements for child care 
institutions and facilities; and State- and institution-level 
monitoring requirements. This rule also includes changes that are 
required by the Healthy Meals for Healthy Americans Act of 1994 (Pub. 
L. 103-448), the Personal Responsibility and Work Opportunities 
Reconciliation Act of 1996 (Pub. L. 104-193), and the William F. 
Goodling Child Nutrition Reauthorization Act of 1998 (Pub. L. 105-336).


The changes are designed to improve program operations and monitoring 
at the State and institution levels and, where possible, to streamline 
and simplify program requirements for State agencies and institutions. 
(95-024)


Statement of Need:


In recent years, State and Federal program reviews have found numerous 
cases of mismanagement, abuse, and in some instances, fraud by child 
care institutions and facilities in the CACFP. These reviews revealed 
weaknesses in management controls over program operations and examples 
of regulatory noncompliance by institutions, including failure to pay 
facilities or failure to pay them in a timely manner; improper use of 
program funds for non-program expenditures; and improper meal 
reimbursements due to incorrect meal counts or to miscategorized or 
incomplete income eligibility statements. In addition, audits and 
investigations conducted by the Office of Inspector General (OIG) have 
raised serious concerns regarding the adequacy of financial and 
administrative controls in CACFP. Based on its findings, OIG 
recommended changes to CACFP review requirements and management 
controls.


Summary of Legal Basis:


Some of the changes proposed in the rule are discretionary changes 
being made in response to deficiencies found in program reviews and OIG 
audits. Other changes codify statutory changes made by the Healthy 
Meals for Healthy Americans Act of 1994 (Pub. L. 103-448), the Personal 
Responsibility and Work Opportunities Reconciliation Act of 1996 (Pub. 
L. 104-193), and the William F. Goodling Child Nutrition 
Reauthorization Act of 1998 (Pub. L. 105-336).


Alternatives:


In developing the proposal, the Agency considered various alternatives 
to minimize burden on State agencies and

[[Page 72674]]

institutions while ensuring effective program operation. Key areas in 
which alternatives were considered include State agency reviews of 
institutions and sponsoring organization oversight of day care homes.


Anticipated Cost and Benefits:


This rule contains changes designed to improve management and financial 
integrity in the CACFP. When implemented, these changes would affect 
all entities in CACFP, from USDA to participating children and 
children's households. These changes will primarily affect the 
procedures used by State agencies in reviewing applications submitted 
by, and monitoring the performance of, institutions which are 
participating or wish to participate in the CACFP. Those changes which 
would affect institutions and facilities will not, in the aggregate, 
have a significant economic impact.


Data on CACFP integrity is limited, despite numerous OIG reports on 
individual institutions and facilities that have been deficient in 
CACFP management. While program reviews and OIG reports clearly 
illustrate that there are weaknesses in parts of the program 
regulations and that there have been weaknesses in oversight, neither 
program reviews, OIG reports, nor any other data sources illustrate the 
prevalence and magnitude of CACFP fraud and abuse. This lack of 
information precludes USDA from estimating the amount of money lost due 
to fraud and abuse or the reduction in fraud and abuse the changes in 
this rule will realize.


Risks:


Continuing to operate the CACFP under existing provisions of the 
regulations that do not sufficiently protect against fraud and abuse in 
CACFP puts the program at significant risk. This rule includes changes 
designed to strengthen current program regulations to reduce the risk 
associated with the program.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            65 FR 55103                                    09/12/00
NPRM Comment Period End                                        12/11/00
Interim Final Ru69 FR 53502                                    09/01/04
Interim Final Rule Effective                                   10/01/04
Interim Final Rule Comment Period End                          09/01/05
Final Action                                                   12/00/06
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Local, State


Federalism:


This action may have federalism implications as defined in EO 13132.


Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 918
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
RIN: 0584-AC24
_______________________________________________________________________

USDA--FNS



10. COMMODITY SUPPLEMENTAL FOOD PROGRAM (CSFP): PLAIN LANGUAGE, PROGRAM 
ACCOUNTABILITY, AND PROGRAM FLEXIBILITY
Priority:


Other Significant


Legal Authority:


PL 101-624; PL 104-127


CFR Citation:


7 CFR 247


Legal Deadline:


None


Abstract:


This rule will rewrite regulations pertaining to the Commodity 
Supplemental Food Program (7 CFR part 247) in ``plain language.'' It 
will also amend regulatory provisions in this part to increase program 
accountability, impose more rigorous performance measures on State and 
local agencies, increase flexibility for program operators, and 
incorporate legislative provisions that have been implemented through 
program policy. (99-005)


Statement of Need:


This rule is necessary to amend regulatory provisions in 7 CFR part 247 
to increase program accountability, impose more rigorous performance 
measures on State and local agencies, increase flexibility for program 
operators and incorporate legislative provisions that have been 
implemented through program policy.


Summary of Legal Basis:


Executive Order 12866 requires each agency to write regulations that 
are simple and easy to understand. The rule meets these requirements. 
This rule also incorporates legislative amendments found in sections 
1771(d) and 1771(e) of the Food, Agriculture, Conservation, and Trade 
Act of 1990; section 402(b) of the Federal Agriculture Improvement and 
Reform Act of 1996; section 4201(b) of the Farm Security and Rural 
Investment Act of 2002; and the Single Audit Act Amendments of 1996.


Alternatives:


No alternatives available.


Anticipated Cost and Benefits:


Changes in the rule reduce the burden imposed on State and local 
agencies while ensuring program accountability and are generally 
insignificant to the costs or overall operations of the program.


Risks:


There are no risks involved with this proposed rule.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            68 FR 62164                                    10/31/03
NPRM Comment Period End                                        12/30/03
Final Action                                                   03/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Local, State, Tribal


Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 918
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
RIN: 0584-AC84

[[Page 72675]]

_______________________________________________________________________

USDA--FNS



11. FSP: HIGH PERFORMANCE BONUSES
Priority:


Other Significant


Legal Authority:


PL 107-171


CFR Citation:


7 CFR 272; 7 CFR 275


Legal Deadline:


None


Abstract:


This action will finalize amendments to the FSP regulations originally 
proposed on December 17, 2003, titled FSP High Performance Bonuses. 
These amendments were provided for in the Farm Security and Rural 
Investment Act of 2002 for States that demonstrate high or improved 
performance in administration of the Food Stamp Program. This action 
will finalize the measurement criteria for fiscal year 2005 and beyond. 
(02-006)


Statement of Need:


This rule is mandated by Public Law 107-171 to implement the 
performance measures used to award high performance bonuses for fiscal 
years 2005 and beyond.


Summary of Legal Basis:


The legal basis for this rule is Public Law 107-171.


Alternatives:


This rule is mandated by law. Therefore, there are no alternatives.


Anticipated Cost and Benefits:


Undetermined


Risks:


The law mandates that we publish the performance measures for the high 
performance bonuses for FY 2005 and beyond.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            68 FR 70193                                    12/17/03
NPRM Comment Period End                                        02/17/04
Final Action                                                   01/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, Local, State, Tribal


Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 918
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
RIN: 0584-AD29
_______________________________________________________________________

USDA--FNS



12. FSP: ELIGIBILITY AND CERTIFICATION PROVISIONS OF THE FARM SECURITY 
AND RURAL INVESTMENT ACT OF 2002
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


PL 107-171, secs 4101 to 4109, 4114, 4115, and 4401


CFR Citation:


7 CFR 273


Legal Deadline:


None


Abstract:


This rulemaking proposes to amend Food Stamp Program regulations to 
implement 11 provisions of the Farm Security and Rural Investment Act 
of 2002 that establish new eligibility and certification requirements 
for the receipt of food stamps.


Statement of Need:


The rule is needed to implement the food stamp certification and 
eligibility provisions of Public Law 107-171, the Farm Security and 
Rural Investment Act of 2002.


Summary of Legal Basis:


The legal basis for this rule is Public Law 107-171, the Farm Security 
and Rural Investment Act of 2002.


Alternatives:


This proposed rule deals with changes required by Public Law 107-171, 
the Farm Security and Rural Investment Act of 2002. The Department has 
limited discretion in implementing provisions of that law. Most of the 
provisions in this rule are effective October 1, 2002, and must be 
implemented by State agencies prior to publication of this rule.


Anticipated Cost and Benefits:


The provisions of this rule will simplify State administration of the 
Food Stamp Program, increase eligibility for the program among certain 
groups, increase access to the program among low-income families and 
individuals, and increase benefit levels. The provisions of Public Law 
107-171 implemented by this rule will have a 5-year cost of 
approximately $1.9 billion.


Risks:


The FSP provides nutrition assistance to millions of Americans 
nationwide--working families, eligible non-citizens, and elderly and 
disabled individuals. Many low-income families don't earn enough money 
and many elderly and disabled individuals don't receive enough in 
retirement or disability benefits to meet all of their expenses and 
purchase healthy and nutritious meals. The FSP serves a vital role in 
helping these families and individuals achieve and maintain self-
sufficiency and purchase a nutritious diet. This rule is intended to 
implement the certification and eligibility provisions of Public Law 
107-171, the Farm Security and Rural Investment Act of 2002. It will 
simplify State administration of the Food Stamp Program, increase 
eligibility for the program among certain groups, increase access to 
the program among low-income families and individuals, and increase 
benefit levels. The provisions of this rule will increase benefits by 
approximately $1.95 billion over 5 years. When fully effective in FY 
2006, the provisions of this rule will add approximately 415,000 new 
participants.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            69 FR 20724                                    04/16/04
NPRM Comment Period End                                        06/15/04
Final Action                                                   10/00/05
Final Action Effective                                         12/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, Local, State, Tribal

[[Page 72676]]

Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 918
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
RIN: 0584-AD30
_______________________________________________________________________

USDA--FNS



13. FSP: NON-DISCRETIONARY QUALITY CONTROL PROVISIONS OF TITLE IV OF 
PUBLIC LAW 107-171
Priority:


Other Significant


Legal Authority:


7 USC 2011 to 2032; PL 107-171


CFR Citation:


7 CFR 273; 7 CFR 275


Legal Deadline:


None


Abstract:


This final rule implements several quality control changes to the Food 
Stamp Act required by sections 4118 and 4119 of title IV of the Farm 
Security and Rural Investment Act of 2002 (Pub. L. 107-171). The 
provisions in this rule affect the following areas: 1) Timeframes for 
completing quality control reviews; 2) timeframes for completing the 
arbitration process; 3) timeframes for determining final error rates; 
4) the threshold for potential sanctions and time period for sanctions; 
5) the calculation of State error rates; 6) the formula for determining 
States' liability amounts; 7) sanction notification and method of 
payment; and 8) corrective action plans. (02-014)


Statement of Need:


The rule is needed to implement the food stamp quality control 
provisions of Public Law 107-171, the Farm Security and Rural 
Investment Act of 2002.


Summary of Legal Basis:


The legal basis for this rule is Public Law 107-171, the Farm Security 
and Rural Investment Act of 2002.


Alternatives:


This interim rule deals with changes required by Public Law 107-171, 
the Farm Security and Rural Investment Act of 2002. The Department has 
no discretion in implementing these provisions of that law. The 
provisions in this rule are effective for the fiscal year 2003 quality 
control review period and must be implemented by FNS and State agencies 
during fiscal year 2003.


Anticipated Cost and Benefits:


The provisions of this rule are not anticipated to have any impact on 
benefit levels or administrative costs.


Risks:


The FSP provides nutrition assistance to millions of Americans 
nationwide. The quality control system measures the accuracy of States 
providing food stamp benefits to the program recipients. This rule is 
intended to implement the quality control provisions of Public Law 107-
701, the Farm Security and Rural Investment Act of 2002. It will 
significantly revise the system for determining State agency 
liabilities and sanctions for high payment error rates.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Interim Final Ru68 FR 59519                                    10/16/03
Interim Final Rule Effective                                   12/15/03
Interim Final Rule Comment Period End                          01/14/04
Final Action                                                   10/00/05
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


Federal, Local, State


Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 918
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
RIN: 0584-AD31
_______________________________________________________________________

USDA--FNS



14. FSP: EMPLOYMENT AND TRAINING PROGRAM PROVISIONS OF THE FARM 
SECURITY AND RURAL INVESTMENT ACT OF 2002
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


PL 107-171


CFR Citation:


7 CFR 273.7


Legal Deadline:


None


Abstract:


This final rule implements revisions to the Food Stamp Employment and 
Training (E&T) Program funding requirements. (02-009)


Statement of Need:


This rule is necessary to implement statutory revisions to E&T Program 
funding provisions.


Summary of Legal Basis:


All provisions of this proposed rule are mandated by Public Law 107-
171.


Alternatives:


The alternative is not to revise current funding rules. This is not 
practical. The current rules have been superseded by changes brought 
about by Public Law 107-171. These changes were effective on May 13, 
2002, the date of enactment of Public Law 107-171.


Anticipated Cost and Benefits:


None.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            69 FR 12981                                    03/19/04
NPRM Comment Period End                                        05/18/04
Final Action                                                   12/00/04
Final Action Effective                                         02/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, Local, State


Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 918
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
RIN: 0584-AD32

[[Page 72677]]

_______________________________________________________________________

USDA--FNS



15.  DIRECT AND DISCRETIONARY CERTIFICATION IN THE SCHOOL MEALS 
PROGRAMS
Priority:


Other Significant


Legal Authority:


PL 108-265, sec 104


CFR Citation:


7 CFR 245


Legal Deadline:


None


Abstract:


Currently a school food authority may ``directly certify'' any child as 
eligible for free or reduced-price school meals, without further 
application, by directly communicating with the appropriate State or 
local agency to obtain documentation of the child's status as a member 
of a food stamp household or a family receiving TANF.


In response to Public Law 108-265, which amended the Richard B. Russell 
National School Lunch Act, 7 CFR 245, Determining Eligibility for Free 
and Reduced Price Meals and Free Milk in Schools, will be revised to 
require that school food authorities ``directly certify'' as eligible 
for free school meals, without further application, any child who is a 
member of a food stamp household. In order to carry out this 
requirement, the law also requires that each State agency enter into an 
agreement with the State food stamp agency to establish procedures 
under which children who are members of food stamp households will be 
directly certified and amends the Food Stamp Act to require State food 
stamp agencies to enter into the required agreements and cooperate in 
carrying out direct certification. The direct certification 
requirements are phased-in. For School Year 2006-2007, school districts 
with an enrollment of 25,000 students or more in the preceding year 
must comply. For School Year 2007-2008, school districts with an 
enrollment of 10,000 students or more in the preceding year must 
comply. For subsequent school years, all districts must comply. Until 
mandatory ``direct certification'' for children in food stamp 
households is fully implemented, the existing permissive authority is 
retained. In addition, this rule adds (to existing authority with 
regard to children in TANF families) permissive authority for school 
food authorities to directly certify homeless children, children served 
by programs under the Runaway and Homeless Youth Act, and migrant 
children. (04-018)


Statement of Need:


The changes made to the Richard B. Russell National School Lunch Act 
concerning direct verification are intended to improve program access, 
reduce paperwork, and improve the accuracy of the delivery of free meal 
benefits. This regulation will implement the statutory changes and 
provide State agencies and local educational agencies with the policies 
and procedures to conduct mandatory and discretionary direct 
certification.


Summary of Legal Basis:


These changes are being made in response to provisions in Public Law 
108-265.


Alternatives:


FNS will be working closely with State agencies to implement the 
changes made by this regulation and will be developing extensive 
guidance materials in conjunction with our cooperators.


Anticipated Cost and Benefits:


This regulation will reduce paperwork, target benefits more precisely, 
and will improve program access of eligible school children.


Risks:


This regulation may require adjustments to existing computer systems to 
more readily share information between schools, food stamp offices, and 
other agencies.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Interim Final Rule                                             06/00/05
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Governmental Jurisdictions


Government Levels Affected:


Local, State


Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 918
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
RIN: 0584-AD60
_______________________________________________________________________

USDA--Food Safety and Inspection Service (FSIS)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




16. PERFORMANCE STANDARDS FOR PUMPED OR MASSAGED BACON
Priority:


Other Significant


Legal Authority:


21 USC 601 et seq


CFR Citation:


9 CFR 424.22(b)


Legal Deadline:


None


Abstract:


FSIS is proposing to revise the regulatory provisions concerning the 
production and testing of pumped or massaged bacon (9 CFR 424.22(b)). 
FSIS is proposing to remove provisions that prescribe the substances 
and amounts of such substances that must be used to produce pumped or 
massaged bacon. FSIS is proposing to replace these provisions with an 
upper limit for nitrite and a performance standard that establishments 
producing pumped or massaged bacon must meet. To meet the proposed 
performance standard, the process used to produce pumped or massaged 
bacon would be required to limit the presence of nitrosamines when the 
product is cooked.


Statement of Need:


FSIS is proposing to replace restrictive provisions concerning the 
processing of pumped or massaged bacon with an upper limit for nitrite 
and a performance standard. The proposed performance standard concerns 
limiting the presence of volatile nitrosamines in pumped or massaged 
bacon. These proposed changes are necessary to make the regulations 
concerning pumped or massaged bacon consistent

[[Page 72678]]

with those governing Hazard Analysis and Critical Control Point (HACCP) 
systems.


Summary of Legal Basis:


Under the Federal Meat Inspection Act (21 U.S.C. 601 to 695), a meat or 
meat food product is adulterated ``if it bears or contains any 
poisonous or deleterious substance that may render it injurious to 
health; but in case the substance is not an added substance, such 
article shall not be considered adulterated under this clause if the 
quantity of such substance in or on such article does not ordinarily 
render it injurious to health'' (21 U.S.C. 601(m)(1)). Volatile 
nitrosamines are deleterious because they are carcinogenic, and though 
not added directly to pumped or massaged bacon, they may be produced 
when the pumped or massaged bacon is fried. Processors can control the 
levels of nitrosamines that may be present when the product is fried by 
controlling the levels of ingoing nitrite and ingoing curing 
accelerators that are used in the production of pumped or massaged 
bacon. In 1978, USDA stated that nitrosamines present at confirmable 
levels in pumped bacon after preparation for eating were deemed to 
adulterate the product. FSIS still maintains that pumped bacon with 
confirmable levels of nitrosamines after preparation for eating is 
adulterated. Under this proposed rule, processors meeting the 
performance standard would control the levels of nitrosamines in the 
finished product by complying with a performance standard.


Alternatives:


No action; performance standards for all types of bacon (not just 
pumped or massaged bacon, as proposed).


Anticipated Cost and Benefits:


Because FSIS is proposing to convert existing regulations to a 
performance standard and is not proposing any new requirements for 
establishments producing pumped or massaged bacon, FSIS does not 
anticipate that this proposed rule would result in any significant 
costs or benefits. Pumped or massaged bacon processing establishments 
whose HACCP plans do not currently address nitrosamines as hazards 
reasonably likely to occur may incur some costs. Also, establishments 
that choose to test their products for nitrosamines after this rule 
becomes effective may incur some costs. Because this rule provides 
establishments the flexibility to develop new procedures for producing 
bacon, this rule may result in profits to processors who develop 
cheaper means of producing product or who develop a pumped or massaged 
bacon product with wide consumer appeal.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           04/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Dr. Daniel L. Engeljohn
Deputy Assistant Administrator, Office of Policy, Program and Employee 
Development
Department of Agriculture
Food Safety and Inspection Service
Room 402 Cotton Annex Building
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 205-0495
Fax: 202 401-1760
Email: [email protected]
RIN: 0583-AC49
_______________________________________________________________________

USDA--FSIS



17. EGG PRODUCTS INSPECTION REGULATIONS
Priority:


Economically Significant. Major status under 5 USC 801 is undetermined.


Unfunded Mandates:


Undetermined


Legal Authority:


21 USC 1031 to 1056


CFR Citation:


9 CFR 590.570; 9 CFR 590.575; 9 CFR 590.146; 9 CFR 590.10; 9 CFR 
590.411; 9 CFR 590.502; 9 CFR 590.504; 9 CFR 590.580; 9 CFR 591; . . .


Legal Deadline:


None


Abstract:


The Food Safety and Inspection Service (FSIS) is proposing to require 
egg products plants and plants pasteurizing shell eggs to develop and 
implement Hazard Analysis and Critical Control Points (HACCP) systems 
and Sanitation Standard Operating Procedures (SOPs). FSIS also is 
proposing pathogen reduction performance standards that would be 
applicable to egg products and pasteurized shell eggs. Plants would be 
expected to develop HACCP systems that ensure products meet the 
pathogen reduction performance standards. Finally, FSIS is proposing to 
amend the Federal egg products inspection regulations by removing 
current requirements for prior approval by FSIS of egg products plant 
drawings, specifications, and equipment prior to their use in official 
plants. The Agency also plans to eliminate the prior label approval 
system for egg products. This proposal will not encompass shell egg 
packers. In the near future, FSIS will initiate non-regulatory outreach 
efforts for shell egg packers that will provide information intended to 
help them to safely process shell eggs intended for human consumption 
or further processing.


The actions being proposed are part of FSIS' regulatory reform effort 
to improve FSIS' egg products food safety regulations, better define 
the roles of Government and the regulated industry, encourage 
innovations that will improve food safety, remove unnecessary 
regulatory burdens on inspected egg products plants, and make the egg 
products regulations as consistent as possible with the Agency's meat 
and poultry products regulations. FSIS is also taking these actions in 
light of changing inspection priorities and recent findings of 
Salmonella in pasteurized egg products.


Statement of Need:


FSIS is proposing to require egg products plants and plants 
pasteurizing shell eggs to develop and implement HACCP systems and 
sanitation SOPs. FSIS also is proposing pathogen reduction performance 
standards that would be applicable to pasteurized shell eggs and egg 
products. Plants would be expected to develop HACCP systems that ensure 
that these products meet the lethality required by the pathogen 
reduction performance standards. In addition, FSIS is proposing to 
amend the Federal egg products inspection regulations by removing 
current requirements for approval by FSIS of egg product plant 
drawings, specifications, and equipment prior to their use in official 
plants. Finally, the Agency plans to eliminate the pre-marketing label 
approval system for egg products but

[[Page 72679]]

to require safe-handling labels on all shell eggs.


The actions being proposed are part of FSIS' regulatory reform effort 
to improve FSIS' shell egg and egg products food safety regulations, 
better define the roles of Government and the regulated industry, 
encourage innovations that will improve food safety, remove unnecessary 
regulatory burdens on inspected egg products plants, and make the egg 
products regulations as consistent as possible with the Agency's meat 
and poultry products regulations. FSIS also is taking these actions in 
light of changing inspection priorities and recent findings of 
Salmonella in pasteurized egg products.


This proposal is directly related to FSIS' PR/HACCP initiative.


Summary of Legal Basis:


This proposed rule is authorized under the Egg Products Inspection Act 
(21 U.S.C. 1031 to 1056). It is not the result of any specific mandate 
by the Congress or a Federal court.


Alternatives:


A team of FSIS economists and food technologists is conducting a cost-
benefit analysis to evaluate the potential economic impacts of several 
alternatives on the public, egg products industry, and FSIS. These 
alternatives include: (1) Taking no regulatory action; (2) requiring 
all inspected egg products plants to develop, adopt, and implement 
written sanitation SOPs and HACCP plans; and (3) converting to a 
lethality-based pathogen reduction performance standard many of the 
current highly prescriptive egg products processing requirements. The 
team will consider the effects of a uniform, across-the-board standard 
for all egg products; a performance standard based on the relative risk 
of different classes of egg products; and a performance standard based 
on the relative risks to public health of different production 
processes.


Anticipated Cost and Benefits:


FSIS is analyzing the potential costs of this proposed rulemaking to 
industry, FSIS and other Federal agencies, State and local governments, 
small entities, and foreign countries. The expected costs to industry 
will depend on a number of factors. These costs include the required 
lethality, or level of pathogen reduction, and the cost of HACCP plan 
and sanitation SOP development, implementation, and associated employee 
training. The pathogen reduction costs will depend on the amount of 
reduction sought and in what classes of product, product formulations, 
or processes.


Relative enforcement costs to FSIS and Food and Drug Administration may 
change because the two agencies share responsibility for inspection and 
oversight of the egg industry and a common farm-to-table approach for 
shell egg and egg products food safety. Other Federal agencies and 
local governments are not likely to be affected.


FSIS has cooperative agreements with four States and the Commonwealth 
of Puerto Rico under which they provide inspection services to egg 
processing plants under Federal jurisdiction. FSIS reimburses the 
States for staffing costs and expenses for full-time State inspectors. 
HACCP implementation may result in a reduction of staffing resource 
requirements in the States and a corresponding reduction of the Federal 
reimbursement. As a result, some States may decide to stop providing 
inspection services and convert to Federal inspection of egg products 
plants.


Egg and egg product inspection systems of foreign countries wishing to 
export eggs and egg products to the U.S. must be equivalent to the U.S. 
system. FSIS will consult with these countries, as needed, if and when 
this proposal becomes effective.


This proposal is not likely to have a significant impact on small 
entities. The entities that would be directly affected by this proposal 
would be the approximately 75 federally inspected egg products plants, 
most of which are small businesses, according to Small Business 
Administration criteria. If necessary, FSIS will develop compliance 
guides to assist these small firms in implementing the proposed 
requirements.


Potential benefits associated with this rulemaking include: 
Improvements in human health due to pathogen reduction; improved 
utilization of FSIS inspection program resources; and cost savings 
resulting from the flexibility of egg products plants in achieving a 
lethality-based pathogen reduction performance standard. Once specific 
alternatives are identified, economic analysis will identify the 
quantitative and qualitative benefits associated with each.


Human health benefits from this rulemaking are likely to be small 
because of the low level of (chiefly post-processing) contamination of 
pasteurized egg products. In light of recent scientific studies that 
raise questions about the efficacy of current regulations, however, it 
is likely that measurable reductions will be achieved in the risk of 
foodborne illness.


Risks:


FSIS believes that this regulatory action may result in a further 
reduction in the risks associated with egg products. The development of 
a lethality-based pathogen reduction performance standard for egg 
products, replacing command-and-control regulations, will remove 
unnecessary regulatory obstacles to, and provide incentives for, 
innovation to improve the safety of egg products.


To assess the potential risk-reduction impacts of this rulemaking on 
the public, an intra-Agency group of scientific and technical experts 
is conducting a risk management analysis. The group has been charged 
with identifying the lethality requirement sufficient to ensure the 
safety of egg products and the alternative methods for implementing the 
requirement. The egg products processing and distribution module of the 
Salmonella enteritidis Risk Assessment, made public June 12, 1998, will 
be appropriately modified to evaluate the risk associated with the 
regulatory alternatives.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           06/00/05
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses, Governmental Jurisdictions


Government Levels Affected:


Federal, State


Federalism:


 Undetermined


Agency Contact:
Dr. Daniel L. Engeljohn
Deputy Assistant Administrator, Office of Policy, Program and Employee 
Development
Department of Agriculture
Food Safety and Inspection Service
Room 402 Cotton Annex Building
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 205-0495
Fax: 202 401-1760
Email: [email protected]
RIN: 0583-AC58

[[Page 72680]]

_______________________________________________________________________

USDA--FSIS



18. FOOD STANDARDS; GENERAL PRINCIPLES AND FOOD STANDARDS MODERNIZATION
Priority:


Other Significant


Legal Authority:


21 USC 601 et seq; 21 USC 451 et seq; 21 USC 321 et seq


CFR Citation:


9 CFR 410; 21 CFR 130


Legal Deadline:


None


Abstract:


The Food Safety and Inspection Service (FSIS) and the Food and Drug 
Administration (FDA) are proposing to modernize their food standards. 
The agencies are proposing a set of general principles for food 
standards. The adherence to these principles will result in standards 
that will better promote honesty and fair dealing in the interest of 
consumers, protect the public, allow for technological advances in food 
production, are consistent with international food standards, and are 
clear, simple, and easy to use for both manufacturers and the agencies 
that enforce compliance with the standards. The proposed general 
principles will establish the criteria that the agencies will use in 
considering whether a petition to establish, revise, or eliminate a 
food standard will be the basis for a proposed rule.


Statement of Need:


This rule is necessary to modernize FDA and FSIS food standards, so 
that they are consistent with the agencies' authorizing statutes, allow 
for technological advances in food production, are consistent with 
international food standards to the extent feasible, and are clear, 
simple, and easy to use for both manufacturers and the agencies that 
enforce compliance with the standards.


Summary of Legal Basis:


Under 21 U.S.C. 341, FDA has authority to fix and establish standards 
of identity, standards of quality, or standards of fill of container 
for food products regulated by FDA, when such regulations will promote 
honesty and fair dealing in the interest of consumers. Similarly, under 
21 U.S.C. 607(c) and 457(b), FSIS has authority to establish meat and 
poultry product standards of identity or composition whenever such 
regulations are necessary for the protection of the public. The 
proposed rule will ensure that FDA and FSIS food standards are 
consistent with the authorizing statutes.


Alternatives:


In addition to the option chosen, the Agencies considered the following 
options: 1) No action; 2) removing all food standards from the 
regulations and treating all foods as nonstandardized foods; 3) using 
Agency resources to review and revise food standards rather than 
relying on external petitions; and 4) requesting external industry 
groups to review, revise, and administer the food standards (private 
certification).


Anticipated Cost and Benefits:


Establishing general principles for food standards ensures that FSIS 
and FDA use a consistent and systematic approach when assessing 
standards. These principles would also apprise external parties of the 
framework FDA and FSIS intend to use when assessing standards, thereby 
reducing the costs for external parties to petition the agencies to 
change standards. An additional benefit is that establishing the set of 
principles specified in this proposed rule ensures that FDA and FSIS 
assess standards with respect to their ability to reduce consumers' 
search costs, while also reducing the likelihood that standards will 
impose unnecessary costs, or reduce competition and thereby increase 
prices.


FSIS and FDA expect the costs associated with this rule to be small and 
the benefits to be relatively substantial. Therefore, the Agencies 
believe that the benefits of establishing the proposed principles 
outweigh the costs.


Risks:


None


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           02/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Robert Post Ph.D.
Director, Labeling and Consumer Protection Staff
Department of Agriculture
Food Safety and Inspection Service
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 205-0279
Email: [email protected]
RIN: 0583-AC72
_______________________________________________________________________

USDA--FSIS



19. PERFORMANCE STANDARD FOR CHILLING OF READY-TO-COOK POULTRY
Priority:


Other Significant


Legal Authority:


21 USC 451 to 470


CFR Citation:


9 CFR 381.66


Legal Deadline:


None


Abstract:


FSIS is proposing a performance standard for the chilling of ready-to-
cook poultry products that is intended to ensure the control of 
microorganisms on the products from a point after evisceration until 
the products are frozen, further processed, or packaged for shipment 
from the processing plant. The current specific time and temperature 
requirements for chilling poultry carcasses of various weights would be 
retained as alternative requirements that poultry processors could 
choose to meet. FSIS is taking this action to provide poultry 
processors with greater flexibility in achieving the purposes of the 
poultry chilling requirements whilst complying with the Agency's Hazard 
Analysis and Critical Control Point (HACCP) and other regulations. This 
proposal responds to petitions from industry trade associations.


Statement of Need:


This proposed rule addresses Federal regulations that are inconsistent 
with the PR/HACCP regulations because they restrict the ability of 
poultry processors to choose appropriate and effective measures to 
eliminate, reduce, or control biological hazards identified in their 
hazard analyses. The regulations also complicate efforts by 
establishments to comply with the terms of the January 9, 2001, final 
rule

[[Page 72681]]

further restricting the amount of water that may be retained in raw 
meat or poultry products after post-evisceration processing; some 
establishments may have to use chilling procedures that result in 
higher levels of retained water in carcasses than may be necessary to 
achieve the same food safety objective. For example, establishments 
that operate automated chillers may have to subject poultry carcasses 
to higher agitation rates or longer dwell times in the chillers. Also, 
as discussed above, the time/temperature chilling regulations for 
poultry are inconsistent with the PR/HACCP regulations, the retained 
water regulations, and the meat inspection regulations.


Summary of Legal Basis:


This regulatory action is authorized under the Poultry Products 
Inspection Act (21 U.S.C. 451 to 470).


Alternatives:


FSIS evaluated five regulatory alternatives: (1) Taking no regulatory 
action; (2) replacing the command-and-control requirements with a 
performance standard; (3) requiring meatpackers, as well as poultry 
processors, to comply with such a performance standard; (4) requiring 
all establishments that prepare raw meat or poultry products or handle, 
transport, or receive the products in transportation to comply with a 
performance standard; or (5) removing the command-and-control 
requirements from the poultry products inspection regulations. The 
Agency chose the second alternative but would make the existing 
requirements a ``safe harbor.''


Anticipated Cost and Benefits:


Poultry processors would gain the flexibility to choose the best 
processing techniques and procedures for achieving production 
efficiencies, meeting HACCP food safety objectives, and preventing 
economic adulteration of raw product with retained water in amounts 
greater than those which are unavoidable for food-safety purposes. They 
would be able to operate with a wider range of chilling temperatures 
consistent with the requirements of the PR/HACCP regulations. The 
poultry products industry could achieve energy efficiencies resulting 
in annual savings of as much as $2.8 million. The industry could also 
reduce carcass ``dwell times'' in immersion chillers and thereby reduce 
the amount of water absorbed and retained by the carcasses. The 
reduction in dwell time might enable some establishments, particularly 
those currently operating at the throughput capacity of their chillers, 
to increase production by installing additional evisceration lines.


Poultry establishments would therefore be able to operate more 
efficiently to provide consumers with product that is not adulterated. 
FSIS also would gain some flexibility by being able to reallocate some 
inspection resources from measuring the temperature of chilled birds to 
such activities as HACCP system verification.


This proposed rule would directly impose no new costs on the regulated 
industry. It would relieve burdens arising from the disparate impacts 
of the current regulations on the meat and poultry industries.


Risks:


None


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           05/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Dr. Daniel L. Engeljohn
Deputy Assistant Administrator, Office of Policy, Program and Employee 
Development
Department of Agriculture
Food Safety and Inspection Service
Room 402 Cotton Annex Building
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 205-0495
Fax: 202 401-1760
Email: [email protected]
RIN: 0583-AC87
_______________________________________________________________________

USDA--FSIS

                              -----------

                            FINAL RULE STAGE

                              -----------




20. PERFORMANCE STANDARDS FOR THE PRODUCTION OF PROCESSED MEAT AND 
POULTRY PRODUCTS
Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


Undetermined


Legal Authority:


21 USC 451 et seq; 21 USC 601 et seq


CFR Citation:


9 CFR 301; 9 CFR 303; 9 CFR 317; 9 CFR 318; 9 CFR 319; 9 CFR 320; 9 CFR 
325; 9 CFR 331; 9 CFR 381; 9 CFR 417; 9 CFR 430; CFR 431


Legal Deadline:


None


Abstract:


FSIS has proposed to establish pathogen reduction performance standards 
for all ready-to-eat (RTE) and partially heat-treated meat and poultry 
products. The performance standards spell out the objective level of 
pathogen reduction that establishments must meet during their 
operations in order to produce safe products but allow the use of 
customized, plant-specific processing procedures other than those 
prescribed in the earlier regulations. Along with HACCP, food safety 
performance standards will give establishments the incentive and 
flexibility to adopt innovative, science-based food safety processing 
procedures and controls, while providing objective, measurable 
standards that can be verified by Agency inspectional oversight. This 
set of performance standards will include and be consistent with 
standards already in place for certain ready-to-eat meat and poultry 
products.


Statement of Need:


The Food Safety and Inspection Service (FSIS) has proposed to amend the 
Federal meat and poultry inspection regulations by establishing food 
safety performance standards for all ready-to-eat and all partially 
heat-treated meat and poultry products. The proposed performance 
standards set forth both levels of pathogen reduction and limits on 
pathogen growth that official meat and poultry establishments must 
achieve during their operations in order to produce unadulterated 
products but allow the use of customized, plant-specific processing 
procedures. The proposed performance standards apply to ready-to-eat 
meat and poultry products, categorized as follows: Dried products 
(e.g., beef or poultry jerky); salt-cured products (e.g., country ham); 
fermented products (e.g., salami and Lebanon bologna); cooked and 
otherwise processed products (e.g., beef and chicken burritos, corned 
beef, pastrami, poultry rolls, and turkey franks); and thermally 
processed, commercially sterile products (e.g.,

[[Page 72682]]

canned spaghetti with meat balls and canned corned beef hash).


Although FSIS routinely samples and tests some ready-to-eat products 
for the presence of pathogens prior to distribution, there are no 
specific regulatory pathogen reduction requirements for most of these 
products. The proposed performance standards will help ensure the 
safety of these products; give establishments the incentive and 
flexibility to adopt innovative, science-based food safety processing 
procedures and controls; and provide objective, measurable standards 
that can be verified by Agency oversight.


The proposal also contained provisions addressing Listeria 
monocytogenes in RTE products. An Interim Final Rule on this subject 
was published June 6, 2003 (68 FR 34208).


FSIS also has proposed to eliminate its regulations that require that 
both ready-to-eat and not-ready-to-eat pork and products containing 
pork be treated to destroy trichinae (Trichinella spiralis). These 
requirements are inconsistent with HACCP, and some will be unnecessary 
if FSIS makes final the proposed performance standards for ready-to-eat 
meat and poultry products.


Summary of Legal Basis:


Under the Federal Meat Inspection Act (21 U.S.C. 601 to 695) and the 
Poultry Product Inspection Act (21 U.S.C. 451 to 470), FSIS issues 
regulations governing the production of meat and poultry products 
prepared for distribution in commerce. The regulations, along with FSIS 
inspection programs, are designed to ensure that meat and poultry 
products are safe, not adulterated, and properly marked, labeled, and 
packaged.


Alternatives:


As an alternative to all of the proposed requirements, FSIS considered 
taking no action. As alternatives to the proposed performance standard 
requirements, FSIS considered end-product testing and requiring ``use-
by'' date labeling on ready-to-eat products.


Anticipated Cost and Benefits:


Benefits are expected to result from less contaminated products 
entering commercial food distribution channels as a result of improved 
sanitation and process controls and in-plant verification. FSIS 
believes that the benefits of the rule would exceed the total costs of 
implementing its provisions.


The main provisions of the proposed rule are: Lethality performance 
standards for Salmonella and E. coli 0157:H7 and stabilization 
performance standards for C. perfringens that firms must meet when 
producing RTE meat and poultry products. Most of the costs of these 
requirements would be associated with one-time process performance 
validation in the first year of implementation of the rule and with 
revision of HACCP plans. Total industry-wide costs are estimated to be 
$7.1 million. Benefits are expected to result from the entry into 
commercial food distribution channels of product with lower levels of 
contamination resulting from improved in-plant process verification and 
sanitation.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            66 FR 12590                                    02/27/01
NPRM Comment Period End                                        05/29/01
NPRM Comment Per66 FR 35112d                                   07/03/01
NPRM Comment Period End                                        09/10/01
Interim Final Ru68 FR 34208                                    06/06/03
Interim Final Rule Effective                                   10/06/03
Interim Final Rule Comment Period End                          12/08/04
Final Action                                                   06/00/05
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Undetermined


Agency Contact:
Dr. Daniel L. Engeljohn
Deputy Assistant Administrator, Office of Policy, Program and Employee 
Development
Department of Agriculture
Food Safety and Inspection Service
Room 402 Cotton Annex Building
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 205-0495
Fax: 202 401-1760
Email: [email protected]
RIN: 0583-AC46
_______________________________________________________________________

USDA--FSIS



21. NUTRITION LABELING OF SINGLE-INGREDIENT PRODUCTS AND GROUND OR 
CHOPPED MEAT AND POULTRY PRODUCTS
Priority:


Other Significant


Legal Authority:


21 USC 601 et seq; 21 USC 451 et seq


CFR Citation:


9 CFR 317; 9 CFR 381


Legal Deadline:


None


Abstract:


FSIS has proposed to amend the Federal meat and poultry products 
inspection regulations to require nutrition labeling for the major cuts 
of single-ingredient, raw meat and poultry products, either on their 
label or at their point-of-purchase, unless an exemption applies. FSIS 
also proposed to require nutrition information on the label of ground 
or chopped meat and poultry products, unless an exemption applies. The 
requirements for ground or chopped products will be consistent with 
those for multi-ingredient products.


FSIS also proposed to amend the nutrition labeling regulations to 
provide that when a ground or chopped product does not meet the 
regulatory criteria to be labeled ``low fat,'' a lean percentage claim 
may be included on the label or in labeling, as long as a statement of 
the fat percentage also is displayed on the label or in labeling.


Statement of Need:


The Agency will require that nutrition information be provided for the 
major cuts of single-ingredient, raw meat and poultry products, either 
on their label or at their point-of-purchase, because during the most 
recent surveys of retailers, the Agency did not find significant 
participation in the voluntary nutrition labeling program for single-
ingredient, raw meat and poultry products. Without the nutrition 
information for the major cuts of single-ingredient, raw meat and 
poultry products that would be provided if significant participation in 
the voluntary nutrition labeling program existed, FSIS has concluded 
that these products would be misbranded.


Because consumers cannot easily estimate the level of fat in ground or 
chopped meat and poultry products and because producers are able to

[[Page 72683]]

formulate precisely the fat content of ground or chopped products, FSIS 
has concluded that ground or chopped meat and poultry products that do 
not bear nutrition information on their labels would also be 
misbranded.


Finally, FSIS will amend the nutrition labeling regulations to provide 
that when a ground or chopped product does not meet the criteria to be 
labeled ``low fat,'' a lean percentage claim may be included on the 
product, as long as a statement of the fat percentage is also displayed 
on the label or in labeling. FSIS will include these provisions in the 
final nutrition labeling regulations because many consumers have become 
accustomed to this labeling on ground beef products and because this 
labeling provides a quick, simple, accurate means of comparing all 
ground or chopped meat and poultry products.


Summary of Legal Basis:


This action is authorized under the Federal Meat Inspection Act (21 
U.S.C. 601 to 695) and the Poultry Products Inspection Act (21 U.S.C. 
451 to 470).


Alternatives:


No action; nutrition labels required on all single-ingredient, raw 
products (major cuts and non-major cuts) and all ground or chopped 
products; nutrition labels required on all major cuts of single-
ingredient, raw products (but not non-major cuts) and all ground or 
chopped products; nutrition information at the point-of-purchase 
required for all single-ingredient, raw products (major and non-major 
cuts) and for all ground or chopped products.


Anticipated Cost and Benefits:


Costs will include the equipment for making labels, labor, and 
materials used for labels for ground or chopped products. The cost of 
providing nutrition labeling for the major cuts of single-ingredient, 
raw meat and poultry products should not be significant, because retail 
establishments would have the option of providing nutrition information 
through point-of-purchase materials.


Benefits of the nutrition labeling rule would result from consumers 
modifying their diets in response to new nutrition information 
concerning ground or chopped products and the major cuts of single-
ingredient, raw products. Reductions in consumption of fat and 
cholesterol are associated with reduced incidence of cancer and 
coronary heart disease.


FSIS has concluded that the quantitative benefits will exceed the 
quantitative costs of the rule.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            66 FR 4970                                     01/18/01
NPRM Comment Period End                                        04/18/01
Extension of Com66 FR 20213                                    04/20/01
NPRM Comment Period End                                        07/17/01
Final Action                                                   02/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Robert Post Ph.D.
Director, Labeling and Consumer Protection Staff
Department of Agriculture
Food Safety and Inspection Service
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 205-0279
Email: [email protected]
RIN: 0583-AC60
_______________________________________________________________________

USDA--FSIS



22. PROHIBITION OF THE USE OF SPECIFIED RISK MATERIALS FOR HUMAN FOOD 
AND REQUIREMENTS FOR THE DISPOSITION OF NON-AMBULATORY DISABLED CATTLE
Priority:


Economically Significant. Major status under 5 USC 801 is undetermined.


Legal Authority:


21 USC 601 et seq


CFR Citation:


Not Yet Determined


Legal Deadline:


None


Abstract:


On January 12, 2004, the Food Safety and Inspection Service (FSIS) 
issued an interim final rule to amend the Federal meat inspection 
regulations to designate the brain, skull, eyes, trigeminal ganglia, 
spinal cord, vertebral column (excluding the vertebrae of the tail, the 
transverse processes of the thoracic and lumbar vertebrae, and the 
wings of the sacrum), and dorsal root ganglia (DRG) of cattle 30 months 
of age and older, and the tonsils and distal ileum of the small 
intestine of all cattle, as ``specified risk materials'' (SRMs). The 
Agency declared that SRMs are inedible and prohibited their use for 
human food. In addition, as a result of the interim final rule, FSIS 
now requires that all non-ambulatory disabled cattle presented for 
slaughter be condemned. The Agency also requires that federally 
inspected establishments that slaughter cattle and federally inspected 
establishments that process the carcasses or parts of cattle develop, 
implement, and maintain written procedures for the removal, 
segregation, and disposition of SRMs. Establishments must incorporate 
these procedures into their HACCP plans or in their Sanitation SOPs or 
other prerequisite program. FSIS took this action in response to the 
diagnosis on December 23, 2003, by the U.S. Department of Agriculture 
of a positive case of bovine spongiform encephalopathy (BSE) in an 
adult Holstein cow in the State of Washington. This action is intended 
to minimize human exposure to materials that scientific studies have 
demonstrated as containing the BSE agent in cattle infected with the 
disease. Infectivity has never been demonstrated in the muscle tissue 
of cattle experimentally or naturally infected with BSE at any stage of 
the disease.


Statement of Need:


FSIS issued an interim final rule to amend the meat inspection 
regulations to add provisions to prevent meat and meat products that 
may contain the BSE agent from entering commerce.


BSE is a chronic, degenerative, neurological disorder of cattle. 
Worldwide, there have been more than 185,000 cases since the disease 
was first diagnosed in 1986 in Great Britain. Recent laboratory and 
epidemiological research indicate that there is a causal association 
between BSE and variant Creutzfeldt-Jakob Disease (vCJD), a slow 
degenerative disease that affects the central nervous system of humans. 
Both BSE and vCJD are always fatal.


USDA policy in regard to BSE has been to be proactive and preventive. 
The regulations: (1) Prohibit certain materials that have been shown to

[[Page 72684]]

contain the BSE agent in BSE-infected cattle to be used for human food 
or in the production of human food; (2) prescribe handling, storage, 
and transportation requirements for such materials; (3) prohibit 
slaughter procedures that may cause potentially infective tissues to 
migrate to edible tissues; (4) prescribe requirements for the 
slaughtering and processing of cattle whose materials are most likely 
to contain the BSE agent if the animal is infected with BSE; and (5) 
prescribe requirements for the sanitation or disposal of plant 
equipment that may be contaminated with the BSE agent.


Summary of Legal Basis:


Under the Federal Meat Inspection Act (21 U.S.C. 601 to 695), FSIS 
issues regulations governing the production of meat and meat food 
products. The regulations, along with FSIS inspection programs, are 
designed to ensure that meat food products are safe, not adulterated, 
and properly marked, labeled, and packaged.


Alternatives:


As an alternative to the interim final rule, FSIS considered taking no 
action. FSIS rejected this option because, as previously mentioned, 
USDA policy in regard to BSE has been to be proactive and preventive.


Anticipated Cost and Benefits:


This interim final rule could result in costs to the regulated 
industry. FSIS expects to minimize the costs by targeting the 
regulations to apply to those cattle whose materials are most likely to 
contain the BSE agent if the animal is infected with BSE. Banning 
certain materials, such as brain and spinal cord, for use as human food 
may require additional staff and time to remove such materials. 
Materials prohibited for use as human food could not be sold 
domestically or exported. Companies may be required to find new ways to 
handle and dispose of these materials, which would impose additional 
costs. Prohibiting the use of bovine vertebral column as a source 
material in AMRS could result in a decrease in product yield and may 
require companies that use these systems to produce boneless beef and 
beef products to find other uses for bovine vertebral column. 
Establishments whose equipment may have been contaminated with the BSE 
agent may have costs associated with sanitation or disposal of plant 
equipment.


FSIS may incur costs to increase inspection and compliance activities 
to ensure that the measures taken to prevent meat and meat food 
products that may contain the BSE agent from entering commerce are 
effective. Producers may receive lower prices from processors, and some 
of their stock may be condemned outright. The price consumers pay for 
meat may rise or fall depending on how the discovery of BSE in the U.S. 
affects consumer demand for beef.


The main benefit of this proposed rule is the prevention of vCJD in the 
United States. There have been over 100 definite and probable cases of 
vCJD detected worldwide since the disease was first identified in 1986 
in the United Kingdom. While vCJD is still considered a rare condition, 
the extent or occurrence of a vCJD epidemic in the United Kingdom 
cannot be determined because of the long incubation period (up to 25 
years). Thus, the interim final rule could have widespread public 
health benefits if it serves to prevent a vCJD epidemic from developing 
in the U.S. Even if vCJD remains a rare condition, this proposed rule 
will still have public health benefits because of the severity of the 
symptoms associated with vCJD and the fact that vCJD is always fatal.


This interim final rule may benefit the meat industry by helping to 
restore confidence in the domestic meat supply. This may limit losses 
to meat slaughter and processing operations in the long run.


Risks:


Although vCJD is a rare condition, the symptoms are severe, and it is 
always fatal. This interim final rule is intended to reduce the risk of 
humans developing vCJD in the U.S. in the event BSE is detected in 
native cattle. The measures implemented by FSIS are intended to 
minimize human exposure to materials from cattle that could potentially 
contain the BSE agent. In April 1998, USDA entered into a cooperative 
agreement with Harvard University's School of Public Health to conduct 
a risk analysis to assess the potential pathways for entry into U.S. 
cattle and the U.S. food supply, to evaluate existing regulations and 
policies, and to identify any additional measures that could be taken 
to protect human and animal health. FSIS used the findings of the risk 
assessment to inform its decision to prohibit certain bovine materials 
for human food.


Unlike bacterial and viral pathogens that may be found in or on meat 
food products, the BSE agent cannot be destroyed by conventional 
methods, such as cooking or irradiation. Also, although it is rare, 
vCJD, the human disease associated with exposure to the BSE agent, is 
generally more severe than the human illnesses associated with exposure 
to bacterial and viral pathogens. Thus, additional measures to reduce 
the risk of human exposure to the BSE agent are necessary to protect 
public health.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Interim Final Ru69 FR 1862                                     01/12/04
Interim Final Rule Comment Period End                          04/12/04
Final Action                                                   12/00/05
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Agency Contact:
Dr. Daniel L. Engeljohn
Deputy Assistant Administrator, Office of Policy, Program and Employee 
Development
Department of Agriculture
Food Safety and Inspection Service
Room 402 Cotton Annex Building
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 205-0495
Fax: 202 401-1760
Email: [email protected]
RIN: 0583-AC88
_______________________________________________________________________

USDA--Forest Service (FS)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




23. STATE PETITIONS FOR INVENTORIED ROADLESS AREA MANAGEMENT
Priority:


Other Significant


Legal Authority:


16 USC 472; 16 USC 529; 16 USC 551; 16 USC 1608; 16 USC 1613; 23 USC 
201; 23 USC 205


CFR Citation:


36 CFR 294 subpart B

[[Page 72685]]

Legal Deadline:


None


Abstract:


On January 12, 2001, the Forest Service published the Roadless Area 
Conservation final rule (the ``roadless rule'') in the Federal Register 
establishing prohibitions on road construction, road reconstruction, 
and timber harvesting in inventoried roadless areas at 36 CFR part 294, 
subpart B (66 FR 3244). Since publication, the roadless rule has been 
challenged by nine lawsuits filed in six judicial districts and in four 
Federal circuits. On July 14, 2003, the U.S. District Court for the 
District of Wyoming issued a permanent injunction order enjoining the 
Department from implementing the roadless rule. That ruling has been 
appealed.


Due to the continued legal uncertainty of providing protection for 
roadless areas through the application of the roadless rule, the Agency 
is proposing to amend the roadless rule by replacing the prohibitions 
of the January 2001 rule with a procedural rule that would set out an 
administrative process for State Governors to petition the Secretary of 
Agriculture to establish or adjust management direction for roadless 
areas within their State. Such petitions would be evaluated and, if 
agreed to, addressed by the Secretary in subsequent rulemaking on a 
State-by-State basis.


Statement of Need:


The Department of Agriculture is committed to conserving and managing 
roadless values and considers inventoried roadless areas an important 
component of the National Forest System. The 2001 roadless rule has 
been the subject of nine lawsuits in Federal district courts in Idaho, 
Utah, North Dakota, Wyoming, Alaska, and the District of Columbia. On 
July 14, 2003, the U.S. District Court for the District of Wyoming 
found the 2001 roadless rule to be unlawful and ordered that the rule 
be permanently enjoined. That ruling has been appealed to the Tenth 
Circuit by intervenors. Due to the continued legal uncertainty 
surrounding the 2001 roadless rule, the Forest Service published a 
proposed rule on July 16, 2004, that would replace it with a 
petitioning process that would provide Governors an opportunity to seek 
establishment of management requirements for inventoried roadless areas 
within their State. This opportunity for State petitions would be 
available for 18 months following the effective date of the final rule. 
It is anticipated that this timeframe will be sufficient for States to 
collaborate effectively with local governments, Indian Tribes, 
stakeholders, and other interested parties to develop proposals that 
consider a full range of public input. A State petition would be 
evaluated and, if accepted by the Secretary of Agriculture, the Forest 
Service would initiate subsequent State-specific rulemaking for the 
management of inventoried roadless areas in cooperation with the State 
involved in the petitioning process and in consultation with 
stakeholders and experts. The Department believes that revising 36 CFR 
part 294 to replace the existing rule with a State petitioning process 
that would allow State-specific consideration of the needs of these 
areas is an appropriate solution to address the challenges of 
inventoried roadless area management. On September 9, 2004, in response 
to several written requests, the Forest Service extended the public 
comment period on the proposed rule until November 15, 2004. The 
Department will issue a final rule after thorough evaluation and 
consideration of public comments.


Summary of Legal Basis:


There is no aspect of this action that is required by statute or court 
order. On January 12, 2001, the Department of Agriculture promulgated a 
regulation to provide for the conservation and management of 
inventoried roadless areas within the National Forest System under the 
principles of the Multiple-Use Sustained-Yield Act of 1960. The 
existing Roadless Area Conservation Rule has been the subject of nine 
lawsuits and on July 14, 2003, was permanently enjoined and set aside 
by the U.S. District Court for the District of Wyoming. That ruling has 
been appealed to the Tenth Circuit by intervenors. This proposal is to 
replace the 2001 enjoined rule.


Alternatives:


Until promulgation of the 2001 roadless rule, the Forest Service 
managed inventoried roadless areas based on management requirements in 
individual land management plans. These plans have been developed for 
each unit of the National Forest System through a public notice and 
comment process, building on years of scientific findings and extensive 
public involvement. These plans typically identify and recommend 
inventoried roadless areas that would be appropriate to be designated 
as wilderness by the Congress and provide guidance on activities and 
uses in these areas. This is the current management situation with the 
2001 roadless rule permanently enjoined. An alternative to the proposed 
rule would be for the management of these areas to revert to the 
management requirements in individual land management plans and not to 
allow Governors to petition the Secretary to adjust the management for 
these areas within their States (no action alternative).


Anticipated Cost and Benefits:


Preliminary estimates of the anticipated costs and benefits of this 
proposed rule have been developed by comparing selected effects if 58.5 
million acres of inventoried roadless areas are managed following the 
prohibitions for road construction and timber management activities in 
the 2001 roadless rule or if these same areas are managed in accordance 
with the existing management requirements contained in individual land 
management plans. Approximately 25 percent of the total acres of 
inventoried roadless areas are in the State of Alaska. About 72 percent 
of the total is in the 11 Western States of Montana, Idaho, Wyoming, 
Washington, Utah, Oregon, New Mexico, Nevada, Colorado, California, and 
Arizona. The remaining 3 percent is scattered among 27 other States. 
While it is currently unknown which States may choose to submit a 
petition for State-specific rulemaking, the Forest Service assumes that 
all 38 States and the Commonwealth of Puerto Rico will do so in the 
first year after the rule is final. The costs to the Forest Service and 
the Department to evaluate and make a decision on a single petition are 
estimated to range from $75,000 to $150,000. Costs could range from 
$25,000 to $100,000 for an individual State submitting a petition. 
Total costs to the 38 States and the Commonwealth of Puerto Rico for 39 
petitions would range from $975,000 to $3,900,000, therefore; and total 
costs to the Government would range from $2,925,000 to $5,850,000. 
Total costs of the rule are therefore estimated to range from 
$3,900,000 to $9,750,000. This proposed rule is expected to provide a 
variety of potential beneficial effects, which include the conservation 
of inventoried roadless areas; the protection of human health and 
safety; the reduction of hazardous fuels and restoration of essential 
wildlife habitats; the assurance of reasonable access to public and 
private property or facilities;

[[Page 72686]]

and the improvement of collaboration and partnerships with States.


Risks:


There are no risks addressed by this proposed rule. The conservation 
and management requirements of inventoried roadless areas on National 
Forest System lands have been developed through the land management 
planning process directed by the National Forest Management Act of 
1976, and these management requirements are and have been consistent 
with all applicable Federal statutes, regulations, and policies. The 
controversy surrounding the management of these lands concerns the 
level of development activities that should be allowed on them. These 
areas were originally identified because they met the criteria for 
potential wilderness, and they are evaluated for their wilderness 
potential in the land management planning process. Certain 
developmental activities such as road construction, road 
reconstruction, or timber management, if allowed, may affect the future 
evaluation and consideration of these areas as potential wilderness.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            69 FR 42636                                    07/16/04
NPRM Comment Period End                                        09/14/04
NPRM Comment Per69 FR 54600d                                   09/09/04
NPRM Comment Period End                                        11/15/04
Final Action                                                   04/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


State


Agency Contact:
Andria D. Weeks
Regulatory Analyst
Department of Agriculture
Forest Service
MS 1134
ATTN: ORMS, D&R Branch Mail Stop 1134
1400 Independence Avenue SW
Washington, DC 20250-0003
Phone: 703 605-4610
Fax: 703 605-5111
Email: [email protected]
RIN: 0596-AC10
_______________________________________________________________________

USDA--FS

                              -----------

                            FINAL RULE STAGE

                              -----------




24. NATIONAL FOREST SYSTEM LAND MANAGEMENT PLANNING
Priority:


Other Significant


Legal Authority:


16 USC et seq; 5 USC 301


CFR Citation:


36 CFR 219 subpart A


Legal Deadline:


None


Abstract:


The Forest Service is adopting a final rule that revises the National 
Forest System Land and Resource Management Planning Rule adopted 
November 9, 2000. The proposed rule was published December 6, 2002 (67 
FR 72770). The proposed changes are a result of a review conducted by 
Forest Service personnel at the direction of the Office of the 
Secretary.


The final rule also responds to internal review and comments received 
after the proposed rule was published on December 6, 2002. This rule is 
intended to improve upon the 2000 rule by providing a planning process 
that is more readily understood, is within the Agency's capability to 
implement, is within anticipated budgets and staffing levels, and 
recognizes the programmatic nature of planning.


Statement of Need:


The President's environmental program includes natural resource 
planning for all units of the National Forest System. In support of 
that effort, the Forest Service is adopting a final rule at 36 CFR part 
219, subpart A, to revise the land management planning rule, published 
on November 9, 2000, governing how future changes in land management 
planning direction will be made and how those changes will be 
documented. The proposed rule was published in the Federal Register on 
December 6, 2002, for a 90-day public comment period. The comment 
period was extended 30 days to April 7, 2003. The proposed rule 
continued to support the major principles of the 2000 rule, which are 
the underlying concepts of sustainability, monitoring and evaluation, 
collaboration, and use of science. The proposed rule, however, improved 
the clarity of the 2000 rule, characterized planning as a continuous 
process, offered two options to provide for diversity of plant and 
animal communities, and provided for plan analysis to be categorically 
excluded from National Environmental Policy Act (NEPA) documentation. 
The Agency received over 195,000 comments on the proposed rule. 
Consideration of these comments will lead to a final rule that better 
enables the Forest Service to be good land stewards by providing the 
clean air and water and wildlife protection the public expects. This 
goal would be accomplished by shifting from a complex, cumbersome, and 
expensive up front planning process, to a streamlined process that 
better involves the public, and shifts resources to land management and 
continual monitoring and evaluation.


Summary of Legal Basis:


The Forest and Rangeland Renewable Resources Planning Act of 1974 (88 
Stat. 476 et seq.), as amended by the National Forest Management Act of 
1976 (NFMA) (90 Stat. 2949 et seq.), requires the Secretary to 
promulgate regulations under the principles of the Multiple-Use 
Sustained-Yield Act of 1960 that set out the process for the 
development and revision of land management plans (16 U.S.C. 1604(g)).


Alternatives:


The Forest Service considered and compared the final planning rule to 
both the 1982 and the 2000 planning regulations. Land management plans 
prepared under the 1982 rule were difficult to prepare, took 5 to 7 
years to complete, and required detailed analytical requirements that 
were of limited use due to the high degree of uncertainty of the 
projections. The 2000 planning rule requires a number of detailed 
analytical requirements, lacks clarity regarding many of these 
requirements, is not flexible enough, and lacks recognition of the 
limits of agency budgets and personnel needed to implement it.


Anticipated Cost and Benefits:


Estimates of the anticipated costs and benefits focused on key 
activities in land and resource management planning for which costs 
could be estimated under the 1982, 2000, and final planning rules. 
Based on costs that can be quantified, this final rule is estimated to 
result in a savings, compared to the expected costs under the 1982 rule 
and compared to the 2000 rule.

[[Page 72687]]

In addition to the anticipated cost savings, numerous intangible 
benefits are expected to result from the final rule. The overall goal 
of the final rule is to develop a planning framework that fosters 
stewardship of the National Forest System lands and improves the 
likelihood of contributing toward the ecological, social, and economic 
components of sustainability. Better decisions provide sustained goods, 
services, and values without impairment of the health of the land. 
These improvements will be based on better collaboration with the 
public, improved monitoring and evaluation, integration of science, and 
a more flexible process that reduces the burden on both the public and 
the Agency. A planning process that addresses public concerns and leads 
to improved health of the public lands has value beyond the cost 
savings estimated in the analysis.


Risks:


The final planning rule will help to reduce the risks of natural 
resource management on National Forest System lands by strengthening 
the Forest Service's ability to respond quickly and effectively to a 
variety of continually changing issues, such as the development of new 
scientific information, new listing of species, the effects of 
wildfire, changes in demographics or the economy, and unforeseen 
effects of plan implementation activities. The final planning rule 
allows for a more flexible approach to planning and reducing risks by 
providing for a continual and adaptive planning cycle involving on-the-
ground project proposal, analysis, and implementation; monitoring and 
evaluation; and plan adjustment. The final planning rule would allow 
flexible implementation of projects to avoid and reduce risks; for 
example, projects to implement the Agency's hazardous fuels reduction 
program.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            67 FR 72770                                    12/06/02
NPRM Comment Period End                                        03/24/03
Final Action                                                   02/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Andria D. Weeks
Regulatory Analyst
Department of Agriculture
Forest Service
MS 1134
ATTN: ORMS, D&R Branch Mail Stop 1134
1400 Independence Avenue SW
Washington, DC 20250-0003
Phone: 703 605-4610
Fax: 703 605-5111
Email: [email protected]
RIN: 0596-AB86
_______________________________________________________________________

USDA--Natural Resources Conservation Service (NRCS)

                              -----------

                            FINAL RULE STAGE

                              -----------




25. EMERGENCY WATERSHED PROTECTION PROGRAM
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


PL 81-516; 33 USC 701; PL 95-334; PL 104-127; 16 USC 2203


CFR Citation:


7 CFR 624


Legal Deadline:


None


Abstract:


A revision is necessary to incorporate changes in the program, which 
have resulted from the passage of the 1996 Farm Bill; to fulfill a 
desire to make the program more responsive and efficient; and to 
respond to concerns of the public and the Agency. The rule is being 
reorganized and several items added.


Statement of Need:


The Emergency Watershed Protection (EWP) Program alleviates threats to 
life and property that remain in the Nation's watersheds in the 
aftermath of natural disasters such as floods, hurricanes, tornadoes, 
and wildfires. The EWP Program is administered by the USDA NRCS, which 
provides technical and financial assistance to local sponsoring 
authorities to preserve life and property threatened by disaster-caused 
erosion and flooding. Funding is provided through congressional 
emergency appropriations. Threats that the EWP Program addresses are 
termed ``watershed impairments.'' These include debris-clogged stream 
channels, undermined and unstable stream banks, jeopardized water 
control structures and public infrastructure, and damaged upland sites 
stripped of protective vegetation by fire or drought. If these 
watershed impairments are not addressed, they would pose a serious 
threat of injury, loss of life, or devastating property damage should a 
subsequent event occur.


NRCS' final rule action is to codify existing EWP Program 
implementation and institute programmatic changes that allow:


1.The repair of enduring conservation practices;


2.Limits repeated site repairs;


3.Allows additional easement purchases;


4.Addresses environmental justice issues; and


5.Limits treatments on federal lands.


To implement the final rule action, NRCS would incorporate changes in 
Program administration and in project execution dealing with 
traditional watershed impairments. It would expand the Program by 
providing to the list of watershed impairments EWP currently addresses:


1.Floodplain sediment deposition removal;


2.Upland wind-borne debris removal; and


3.Repair damaged structural conservation practices.


The purpose and need for the NRCS final rule action are to provide 
administrative transparency that ensures that the public is fully 
informed of program operations. Program delivery improvements are 
designed to enable NRCS field and State office personnel to pro EW 
assistance more effectively and efficiently. The improvements would 
more fully, equitably, and consistently meet the needs of people 
requiring emergency assistance. Program improvements are designed to 
address environmental, economic, and social concerns and values.


Summary of Legal Basis:


The regulation for EWP, 7 CFR 624, was first promulgated in 1973. The 
EWP Program was authorized by section 216 of the Flood Control Act of 
1950 (Pub. L. 81-516) by amending the Flood Control Act of 1944 (Pub. 
L. 78-534).

[[Page 72688]]

The EWP Manual documents NRCS policy governing EWP; the National EWP 
Handbook provides field procedures. NRCS staff administers EWP in the 
field when sponsors request assistance with disaster damage. NRCS staff 
completes Disaster Survey Reports (DSRs) describing the watershed 
impairments at a particular site, their eligibility for repairs, the 
cost and benefits of appropriate conservation measures, the social 
impacts, and the environmental and technical soundness of the measures. 
The NRCS EWP implementing documents, manual, and handbook (including 
the DSR) will be revised to reflect any program changes in the EWP 
regulation. This means of assessing that net social benefits exceed net 
social costs on each individual DSR site assures that NRCS complies 
with the expectations of public process.


Section 382 of the Federal Agricultural Improvement and Reform Act of 
1996, the 1996 Farm Bill, authorizes the acquisition of floodplain 
easements on flood prone lands as an alternative to traditional 
eligible EWP recovery practices. The floodplain easement acquisition 
component is fully voluntary and complements the traditional recovery 
practices to provide a more permanent solution to repetitive disaster 
assistance payments. This achieves greater environmental and societal 
benefits where the situation warrants and the affected landowner is 
willing to participate in the easement approach.


Alternatives:


Prioritized Watershed Planning and Management.


Anticipated Cost and Benefits:


Same under each option since Congress and Administration establish the 
appropriation. EWP is funded through emergency supplemental 
appropriations.


Risks:


Program delivery improvements through the promulgation of regulation 
are designed to enable NRCS field and State office personnel with EWP 
Program responsibility to provide EWP assistance more effectively and 
efficiently when and where it is needed. The improvements would more 
fully, equitably, and consistently meet the needs of people requiring 
emergency assistance. Program defensibility improvements are designed 
to address environmental, economic, and social concerns and values.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            68 FR 65202                                    11/19/03
NPRM Comment Period End                                        01/20/04
Final Action                                                   12/00/04
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None


Agency Contact:
Victor Cole
National EWP Leader
Department of Agriculture
Natural Resources Conservation Service
Room 6019-S
PO Box 2890
Washington, DC 20013
Phone: 202 690-4575
Fax: 202 720-2143
Email: [email protected]
RIN: 0578-AA30
_______________________________________________________________________

USDA--NRCS



26. TECHNICAL SERVICE PROVIDER ASSISTANCE
Priority:


Other Significant


Legal Authority:


16 USC 3842


CFR Citation:


7 CFR 652


Legal Deadline:


None


Abstract:


Third Party Vendor assistance will allow producers to obtain technical 
services from the department or entities by a certification process. 
This process will distinguish between certification of an individual 
working under his or her own auspices and that of an organization such 
as a corporation or a public agency which has individuals working on 
its behalf. Certification of an individual means the individual has the 
requisite education and technical expertise to perform the technical 
services. Certification of an entity or public agency means that the 
organization may receive payment for the services provided by 
individuals working under its auspices, but the work must be performed 
or warranted by certified individuals and the organization must assume 
the liability for the quality of work performed.


Statement of Need:


In 1994, the Department of Agriculture reorganized and transferred 
increased responsibilities for administration of conservation programs 
to the Natural Resources Conservation Service (NRCS) to provide 
technical and financial assistance to producers to improve the natural 
resource conditions on their land. The Federal Agricultural Improvement 
and Reform Act of 1996 (the 1996 Farm Bill), Public Law 104--127, 
created several new conservation programs for which the Secretary of 
Agriculture delegated administrative responsibility to NRCS.


Through the implementation of its conservation programs, NRCS utilizes 
its technical expertise to provide producers with information to help 
them make land management decisions. When a producer applies to 
participate in a conservation program, NRCS helps the producer evaluate 
the resource conditions on their land to determine the most appropriate 
way to meet the producer's conservation objectives. Through its 
conservation planning process, NRCS helps the producer develop a 
conservation plan and, depending upon the availability of funds, the 
Department provides financial assistance to the producer to implement 
identified conservation practices or systems. The Farm Security and 
Rural Investment Act of 2002 (the 2002 Farm Bill), Public Law 107--171, 
expanded the availability of financial and technical assistance funds 
for the implementation of conservation programs. At the time of 
enactment, the Congressional Budget Office estimated that the 2002 Farm 
Bill represented a $17 billion increase in the level of funding for 
conservation programs.


The current staffing levels of NRCS are insufficient to adequately meet 
the increased need for technical assistance under the conservation 
programs authorized or reauthorized by the 2002 Farm Bill. Section 2701 
of the 2002 Farm Bill amended section 1242 of the Food Security Act of 
1985 (Food Security Act), as amended, to require the Secretary of 
Agriculture to provide technical assistance er the Food Security Act 
conservation programs to a producer eligible for that assistance 
``directly ... or at the option of the producer, through a payment ... 
to the producer for an approved third party, if available.'' The 
Secretary of Agriculture delegated authority to implement section 1242 
to NRCS.


Section 1242 of the Food Security Act greatly expanded the availability 
of technical assistance to producers by

[[Page 72689]]

encouraging other potential providers of technical assistance to assist 
in the delivery of technical services. To ensure that high quality 
technical services are available to all producers, section 1242 
requires the Secretary of Agriculture to establish, by regulation, a 
system for ``approving individuals and entities to provide technical 
assistance to carry out programs under the [Farm Bill] ... and 
establishing the amounts and methods for payments for that 
assistance.''


NRCS published an interim final rule on November 21, 2002, that 
established a certification process under which NRCS evaluated and 
approved individuals, entities, and public agencies as eligible to 
provide conservation technical services for certain conservation 
programs. The interim final rule also established the criteria by which 
NRCS will evaluate all potential providers of technical assistance.


On March 24, 2003, NRCS published an amendment to the interim final 
rule, establishing the process for determining payment levels for 
technical service provider assistance. In addition the amendment set 
forth the policy regarding subcontracting by technical service 
providers in the course of their delivery of technical services. The 
amendment also clarified the process for certification and amended the 
definition of technical service provider. The March 24, 2003, amendment 
had a 90-day comment period. NRCS received 15 comments from seven 
entities to this amendment.


On July 9, 2003, NRCS published a second amendment to the interim final 
rule, establishing a limited exception to tification and payment 
requirements when the Department is partnering with State, local, or 
tribal governments to carry out its duties to provide technical 
services. The July 9, 2003, amendment had a 30-day comment period. NRCS 
received 25 comments from 11 entities to this second amendment.


The final rule will establish the regulatory framework for technical 
service provider assistance for FY 2005 and thereafter, and will 
provide response to public comment.


Summary of Legal Basis:


Section 2701 of the 2002 Farm Bill amended section 1242 of the Food 
Security Act of 1985 (Food Security Act), as amended, to require the 
Secretary of Agriculture to provide technical assistance under the Food 
Security Act conservation programs to a producer eligible for that 
assistance ``directly ... or at the option of the producer, through a 
payment ... to the producer for an approved third party, if 
available.'' The Secretary of Agriculture delegated authority to 
implement section 1242 to NRCS.Section 1242 of the Food Security Act 
greatly expanded the availability of technical assistance to producers 
by encouraging other potential providers of technical assistance to 
assist in the delivery of technical services. To ensure that high 
quality technical services are available to all producers, section 1242 
requires the Secretary of Agriculture to establish, by regulation, a 
system for ``approving individuals and entities to provide technical 
assistance to carry out programs under the [Farm Bill] ... and 
establishing the amounts and methods for payments for that 
assistance.``


Alternatives:


Secretary of Agriculture is required by statute to provide conservation 
program participants the ability to acquire qualified third-party 
technical assistance. Alternative is to not implement statute as 
required.


Anticipated Cost and Benefits:


$153 million benefits and annual costs of $77 million, of which only an 
estimated $28 million annually is cost associated with this rule.


Risks:


USDA conservation program participants will not be able to obtain the 
technical assistance needed to implement conservation practices and the 
associated benefits to the Nation's natural resource base.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Interim Final Ru67 FR 70119                                    11/21/02
Interim Final Rule Comment Period End                          02/19/03
Interim Final Rule Effective                                   03/01/03
Interim Final Ru68 FR 14131                                    03/24/03
Interim Final Rule Comment Period End                          06/23/03
Final Action                                                   12/00/04
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None


Federalism:


 This action may have federalism implications as defined in EO 13132.


Agency Contact:
Sylvia Gillen
Coordinator, Technical Service Providers
Department of Agriculture
Natural Resources Conservation Service
Room 5205-S
PO Box 2890
Washington, DC 20013-2890
Phone: 202 720-6775
Fax: 202 720-3052
Email: [email protected]
RIN: 0578-AA35
_______________________________________________________________________

USDA--NRCS



27. CONSERVATION SECURITY PROGRAM
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


16 USC 3838


CFR Citation:


7 CFR 1470


Legal Deadline:


None


Abstract:


Under the Conservation Security Program (CSP) NRCS is authorized to 
provide financial and technical assistance to owners and operators of 
agricultural operations to promote conservation and improvement of the 
quality of soil, water, air, energy, plant and animal life, and other 
conservation purposes.


Statement of Need:


USDA intends that CSP will recognize those farmers and ranchers, the 
land stewards, who meet the highest standards of conservation and 
environmental management. By managing all of the natural resources on 
their farms and ranches in a sustainable fashion to these high 
standards, stewards of the land benefit themselves, their communities, 
and society as a whole. CSP can be an important tool for those stewards 
and others who strive towards the highest standards of conservation and 
environmental management. CSP helps sustain the economic well-being of 
those farmers and ranchers who reach this pinnacle of good land 
stewardship and enhance the ongoing production of clean water and clean 
air on their farms

[[Page 72690]]

and ranches, which are valuable commodities to all Americans.


The fundamental philosophy and intent of CSP is to support ongoing 
conservation stewardship of working agricultural lands by providing 
payments and assistance to producers to maintain and enhance the 
condition of the resources. To implement the Secretary's vision, the 
program will reward owners and operators of agricultural lands for 
their conservation stewardship efforts and assist them with the 
implementation and maintenance of additional conservation measures that 
can improve the natural resource conditions of their agricultural 
operations. CSP particularly targets producers and activities that can 
provide the greatest additional benefits for the resource concerns 
identified in this rule and in CSP signup announcements. NRCS is 
additionally encouraging those who do not meet the sign-up requirements 
for CSP to initiate a review of the natural resource conditions on 
their land and begin or continue moving toward achieving the minimum 
conservation requirements to enter CSP at a later signup. Other USDA 
programs may be available for technical or financial assistance to help 
them achieve their resource management goals.


Summary of Legal Basis:


The Farm Security and Rural Investment Act of 2002 (Pub. L. 107-171, 
May 13, 2002) (the Act) amended the Food Security Act of 1985 (16 
U.S.C. 3801 et seq.) to authorize the Conservation Security Program 
(CSP). The program is administered by USDA's Natural Resources 
Conservation Service (NRCS). The CSP is a voluntary program that 
provides financial and technical assistance to producers who advance 
the conservation and improvement of soil, water, air, energy, plant, 
and animal life and other conservation purposes on tribal and private 
working lands. Such lands include cropland, grassland, prairie land, 
improved pasture, and range land, as well as forested land and other 
non-cropped areas that are an incidental part of the agriculture 
operation.


As originally enacted, the Conservation Security Program was an 
entitlement program where many producers would have received payments 
if they were eligible. Subsequent to the enactment of the 2002 Act, the 
Omnibus Bill of 2003 amended the Act to limit CSP's total expenditures 
to a total of $3.77 billion over 11 years (fiscal year 2003 through 
fiscal year 2013). When developing the regulations to implement CSP, 
USDA confronted several challenges. The greatest challenge, however, 
was to design a new conservation entitlement program with a cap on its 
total expenditures over multiple years. Statute did not provide 
direction as to how the Secretary should implement a broad entitlement 
program with the statutory fiscal constraints.The limits imposed by the 
budget cap greatly reduce the potential scope of the program. For 
example, USDA's Economic Research Service (ERS) estimates that over 1.8 
million farms and ranches may be eligible for CSP, using the land 
eligibility criteria found in the authorizing legislation. If all of 
these agricultural operations were enrolled, the cost of the program 
would exceed the $3.77 billion cap potentially in the first sign-up. In 
contract, NRCS estimates that the budget cap would allow less than 
50,000 total agricultural operations to participate over the life of 
the program. Estimates derived from a variety of analyses indicate that 
the average Tier III contract, based on nationally averaged data, could 
be near $15,000 per year. If contracts were an average of 7 years in 
duration, the statutory funding could support an estimated 30,000 Tier 
III contracts. The average Tier I and Tier II contracts could be near 
$7,000 annually. If contracts were to average 5 years in duration, the 
statutory funding could support an estimated 90,000 Tier I and II 
contracts.


Furthermore, NRCS expects that a large number of producers will seek 
participation in CSP and ask for assistance to determine their 
potential eligibility for the program. Thus, the statutory cap on 
technical assistance of 15 percent becomes another limiting factor for 
implementing CSP. By law, NRCS cannot incur technical assistance costs 
for NRCS employees or approved technical assistance providers in excess 
of 15 percent of the available funds.


Alternatives:


NRCS Preferred Approach:


1. Limit sign-ups: Conduct periodic CSP sign-ups.


2. Eligibility: Criteria should be sufficiently rigorous to ensure that 
participants are committed to conservation stewardship. Additionally, 
eligibility criteria should ensure that the most pressing resource 
concerns are addressed.


3. Contracts requirements should be sufficiently rigorous to ensure 
that participants undertake and maintain high levels of stewardship.


4. Prioritize funding to ensure that those producers with the highest 
commitment to conservation are funded first.


5. Structure payments to ensure that environmental benefits will be 
achieved.


Alternative Approaches:


1. Prioritize funding based on environmental considerations (e.g., high 
priority watersheds) with consideration given to past historical 
conservation.


2. Apportion the limited budget according to a formula of some kind, 
for example by discounting each participant's contract payments equally 
(i.e., prorate payments).


3. Close signup once available funds are exhausted (i.e., first come, 
first served).


4. Limit the number of tiers of participation offered.


5. Only allow historic stewards to participate--only those who have 
already completed the highest conservation achievement would be funded.


Anticipated Cost and Benefits:


NRCS developed a simulation model to analyze CSP benefits and costs. 
The model assesses producer participation and the overall benefits and 
costs to society associated with that participation. The model is based 
on a series of composite farms, replicating the process of calculating 
the CSP participation decision. Given farm-level estimates of 
participation, enrolled acreage, payments, and costs, the model 
estimates on-site and environmental (off-site) benefits, net economic 
costs, Government costs, Government-to-producer transfer payments, net 
benefit to society, and the benefit-cost ratio.


The model calculates the overall CSP payment by calculating several 
payment components individually, and then by summing the results of: 
The base payment, cost-sharing for installation of new structural 
practices and adoption of new land management practices, cost-sharing 
for maintenance of existing structural and land management practices, 
and enhancement payments. The Net Present Value (NPV) of each payment 
is determined by a payment rate per acre, the number of acres to which 
the payment applies, contract years in which the payment is made (i.e., 
whether the payment is made on a one-time or annual basis), discounted 
to the

[[Page 72691]]

present using a 7 percent annual discount rate. Payments for structural 
and land management practices were calculated using a methodology 
similar to that used for the Environmental Quality Incentives Program 
(EQIP) Benefit/Cost Analysis, Final Report, May 29, 2003.


Although the analysis provides estimates of the social net benefits of 
each alternative examined, its primary value is to illustrate the 
relative order of the identified alternatives, rather than provide 
accurate estimates of the costs and benefits. NRCS based its estimates 
on a number of assumptions because of substantial data gaps. There is, 
for example, no available information on the benefits associated with 
major program elements, such as enhancement activities above and beyond 
the non-degradation level. Instead, the RIA used estimates generated 
from experience with EQIP, CRP, and other USDA conservation programs. 
NRCS also assumes that producers would enroll in CSP if the program 
provided any positive net benefit to them (i.e., even as small as $1). 
This assumption does not take into consideration producers' cash flow 
constraints, which along with other factors could affect participation. 
Since the analysis does not have information on the behavioral response 
of producers to the incentives provided by CSP, the benefits analysis 
provided in the RIA is largely a hypothetical construct and does not 
reflect the benefits of the proposed program and the identified 
alternatives. NRCS intends to refine the analysis for the final rule.


Risks:


By issuing the proposed rule, NRCS builds upon the public input it 
received during the comment period associated with its ANPRM and is 
obtaining additional public comment on the implementation of a new, 
innovative conservation program. The proposed rule provides the public 
an opportunity to participate in the NRCS formation of program policies 
and procedures prior to NRCS publishing a final rule for the program.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            69 FR 193                                      01/02/04
NPRM Comment Period End                                        03/02/04
Final Action                                                   12/00/04
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None


Agency Contact:
Martha Joseph
Resource Conservationist
Department of Agriculture
Natural Resources Conservation Service
Room 6027-S
P.O. Box 2890
Washington, DC 20013
Phone: 202 720-7157
Fax: 202 720-2143
Email: [email protected]
RIN: 0578-AA36
_______________________________________________________________________

USDA--NRCS



28. GRASSLAND RESERVE
Priority:


Other Significant


Legal Authority:


PL 107-171; 16 USC 3838


CFR Citation:


Not Yet Determined


Legal Deadline:


None


Abstract:


Under Grassland Reserve Program (GRP) the Department enters into 
easement or rental agreements with owners of grazing land to protect 
and restore such lands. The Department will designate payment for cost 
share to restore the functions and values of grasslands.


Statement of Need:


Historically, grassland and shrublands occupied approximately one 
billion acres, about half the landmass of the 48 contiguous United 
States (Richard Conner, Texas A&M, June 2001). Roughly 50 percent of 
these lands have been converted to cropland, urban land, and other land 
uses. Privately owned grasslands (pastureland and rangeland) cover 
approximately 526 million acres in this country (1997 National Resource 
Inventory (NRI)). Grasslands provide both ecological and economic 
benefits to local residents and society in general. Grassland 
importance lies not only in the immense area covered but also in the 
diversity of benefits they produce. These lands provide water for urban 
and rural uses, livestock products, flood protection, wildlife habitat, 
and carbon sequestration. These lands also provide aesthetic value in 
the form of open space and are vital links in the enhancement of rural 
social stability and economic vigor, as well as being part of the 
Nation's history.


Grassland loss through conversion to other land uses such as cropland, 
parcels for home sites, invasion of woody or non-native species, and 
urban development threatens grassland resources. About 24 million acres 
of grasslands and shrublands were converted to cropland or non-
agriculture uses between 1992 through 1997 (1997 National Resource 
Inventory).


In the 2002 Farm Bill amendments to the Food Security Act of 1985 (the 
1985 Act), Congress authorized the establishment of GRP. GRP is a 
voluntary program to assist landowners and agriculture operators in 
restoring and protecting grassland and land that contains forbs and 
shrublands. The 2002 Farm Bill provided that $254 million would be made 
available through FY 2007 to enroll no more than 2 million restored or 
improved grasslands. The statute requires that 40 percent of the 
program funds be used for 10-year, 15-year, and 20-year rental 
agreements, and 60 percent of the funds be used for 30-year rental 
agreements and easements.


The Secretry of Agriculture delegated the authority to administer GRP 
on behalf of the Commodity Credit Corporation, to the Chief, Natural 
Resources Conservation Service (NRCS) and the Administrator, Farm 
Service Agency (FSA). These agency leaders are Vice Presidents of the 
CCC. NRCS has the lead responsibility on technical issues and easement 
administration, and FSA has the lead responsibility for rental 
agreement administration and financial activities. The Secretary also 
delegated authority to the Forest Service to hold easements at the 
option of the landowner on properties adjacent to USDA Forest Service 
properties. At the State level, the NRCS State Conservationist and the 
FSA State Executive Director will determine how best to utilize the 
human resources of both agencies to deliver the program and implement 
National policies in an efficient manner.


Summary of Legal Basis:


The Farm Security and Rural Investment Act of 2002 (2002 Farm Bill) 
amended chapter 2, subtitle D of title XII of the Food Security Act of 
1985, to add subchapter C authorizing the Grassland Reserve Program 
(GRP), 16 U.S.C. 3838n to 3838q. The purpose of this program is to 
assist landowners and others in restoring and protecting

[[Page 72692]]

eligible grassland and certain other lands through rental agreements 
and easements. CCC published an interim final rule on May 21, 2004 (60 
FR 29173), and requested public comment. This final rule responds to 
comments received from the public comment period and sets forth how the 
Secretary of Agriculture (the Secretary), using the funds, facilities, 
and authorities of the Commodity Credit Corporation (CCC), will 
implement GRP to meet the statutory objectives of the program.


Alternatives:


Continue implementation under current interim final rule.


Anticipated Cost and Benefits:


$254 million through FY 2007.


Risks:


Grasslands are being lost through urban expansion, cropland conversion, 
or encroachment of invasive species. The Grassland Reserve Program 
assists farmers and ranchers in the restoration and conservation of the 
Nation's grasslands.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Interim Final Ru69 FR 29173                                    05/21/04
Interim Final Rule Comment Period End                          07/20/04
Final Action                                                   12/00/04
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None


Agency Contact:
Leslie Deavers
Watersheds and Wetlands Division
Department of Agriculture
Natural Resources Conservation Service
Washington, DC 20013
Phone: 202 720-1067
Fax: 202 720-2143
Email: [email protected]
RIN: 0578-AA38
_______________________________________________________________________

USDA--NRCS



29. CONFIDENTIALITY OF CONSERVATION PROGRAM INFORMATION
Priority:


Other Significant. Major status under 5 USC 801 is undetermined.


Legal Authority:


5 USC 552(b)(3)


CFR Citation:


7 CFR 609


Legal Deadline:


None


Abstract:


Section 1244 of the Food Security Act of 1985, as amended by the Farm 
Security and Rural Investment Act of 2002, prohibits the release and 
disclosure of proprietary information unless certain exceptions apply. 
Once implemented, the regulations will ensure program participant 
confidence that proprietary information will not be released and 
disclosed and will ensure that the public benefits provided by the 
conservation programs will not be undermined.


Statement of Need:


The Natural Resources Conservation Service (NRCS) implements several 
conservation programs, including its conservation technical assistance 
activities under the Soil Conservation and Domestic Allotment Act and 
many of the technical and financial assistance activities under 
subtitle D of the Food Security Act of 1985. Through the implementation 
of these conservation programs, NRCS utilizes its technical expertise 
to provide owners, operators, and producers with information to help 
them make land management decisions. When an owner, operator, or 
producer applies for financial assistance under a conservation program, 
NRCS evaluates the resource conditions on their land in relation to 
natural resource program priorities.


Program participants provide NRCS with detailed information about the 
condition of their land and their agricultural operations to help 
ensure that they obtain the best technical assistance available and 
that their investment, augmented with NRCS financial assistance, is 
well-targeted. Program participants consider much of the information 
provided to NRCS as proprietary and might be reluctant to work with 
NRCS if such information could be disclosed as public information under 
the Freedom of Information Act (FOIA).


The voluntary adoption of conservation practices on agricultural land 
reaps great public benefits in soil loss reduction, water quality 
improvement, water conservation, wildlife habitat development, and 
wetland restoration. The Farm Security and Rural Investment Act of 2002 
(the 2002 Act) greatly expanded the funding available to implement NRCS 
conservation programs. The 2002 Act also included a provision to 
protect information about program participants and their agricultural 
operations to help ensure that agricultural producers would continue to 
participate voluntarily in the expanded availability of conservation 
programs. Otherwise, the public availability of program participant 
information could undermine the successful voluntary adoption of 
conservation practices that provide so many public benefits.


Summary of Legal Basis:


Section 1244 of the Food Security Act of 1985, as amended by the Farm 
Security and Rural Investment Act of 2002, prohibits the release and 
disclosure of such information unless certain exceptions apply.


Section 1244 of the Food Security Act of 1985, as amended, balances the 
public right to information to ensure an open Government and an 
informed citizenry while protecting the privacy rights of program 
participants from opening up their proprietary information to 
competitors or to the wider public. First, section 1244 provides that 
the provision is pursuant to section 552a ... . Of title 5 of the 
United States Code. Section 552a... is part of FOIA and provides for 
additional protection from disclosure of documentation. Thus, section 
1244 provides protection from disclosure or release of information that 
otherwise would be subject to release under FOIA.


In particular, information provided by program participants may not be 
subject to release to the public based upon either the Privacy Act or 
an exemption from release under FOIA. Under Exemption 4 of FOIA, 
program participants may receive protection from disclosure of 
commercial or financial information voluntarily provided to the 
government. However, disclosure under exemption 4 is discretionary, and 
current executive orders provide that, whenever possible, Federal 
agencies should exercise their discretion to release the information. 
Section 1244 removes this discretion of the Federal agency. Even if 
information could be released under Exemption 4 of FOIA or under the 
Privacy Act, section 1244 requires that NRCS not disclose or release 
the information.


While protecting program participants from having their proprietary 
information considered public information, section 1244 ensures that 
the public maintains its ability to

[[Page 72693]]

obtain payment information regarding conservation program participants.


Alternatives:


The Secretary of Agriculture is required to maintain the 
confidentiality of proprietary information provided by conservation 
program participants. Alternative is to not implement statute as 
required or not to obtain proprietary information from program 
participants. Either alternative is unacceptable.


Anticipated Cost and Benefits:


Undetermined at this time.


Risks:


Without regulatory framework, USDA employees are at risk for 
prosecution for releasing information that is required to be withheld 
from disclosure. Such disclosure has financial penalties.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Final Action                                                   12/00/04
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


State


Agency Contact:
Dwight Halman
Deputy Chief for Management
Department of Agriculture
Natural Resources Conservation Service
P.O. Box 2890
Washington, DC 20013
Phone: 202 720-2588
Email: [email protected]
RIN: 0578-AA40
BILLING CODE 3410-90-S

[[Page 72694]]


DEPARTMENT OF COMMERCE (DOC)



Statement of Regulatory and Deregulatory Priorities
Enhancing long-term economic growth is a central focus of the 
President's policies and priorities. The mission of the Department of 
Commerce is to promote job creation, economic growth, technological 
competitiveness, sustainable development, and improved living standards 
for all Americans by working in partnership with businesses, 
universities, communities, and workers to:
 Build for the future and promote U.S. economic 
            competitivenessin the global marketplace by strengthening 
            and safeguarding the Nation's economic infrastructure;
 Keep America competitive with cutting-edge science and 
            technology and an unrivaled information base; and
 Provide effective management and stewardship of our Nation's 
            resources and assets to ensure sustainable economic 
            opportunities.
The DOC mission statement, containing our three strategic themes, 
provides the vehicle for understanding the Department's aims, how they 
interlock, and how they are to be implemented through our programs. 
This statement was developed with the intent that it serve as both a 
statement of departmental philosophy and as the guiding force behind 
the Department's programs.
The importance that this mission statement and these strategic themes 
have for the Nation is amplified by the vision they pursue for 
America's communities, businesses, and families. Commerce is the 
smallest Cabinet agency, yet our presence is felt, and our 
contributions are found, in every State.
The DOC touches Americans, daily, in many ways--we make possible the 
weather reports that all of us hear every morning; we facilitate the 
technology that all of us use in the workplace and in the home each 
day; we support the development, gathering, and transmitting of 
information essential to competitive business; we make possible the 
diversity of companies and goods found in America's (and the world's) 
marketplace; and we support environmental and economic health for the 
communities in which Americans live.
The DOC has a clear and powerful vision for itself, for its role in the 
Federal Government, and for its roles supporting the American people, 
now and in the future. We confront the intersection of trade promotion, 
civilian technology, economic development, sustainable development, and 
economic analysis, and we want to provide leadership in these areas for 
the Nation.
We work to provide programs and services that serve our country's 
businesses, communities, and families, as initiated and supported by 
the President and the Congress. We are dedicated to making these 
programs and services as effective as possible, while ensuring that 
they are being delivered in the most cost-effective ways. We seek to 
function in close concert with other agencies having complementary 
responsibilities so that our collective impact can be most powerful. We 
seek to meet the needs of our customers quickly and efficiently, with 
programs, information, and services they require and deserve.
As a permanent part of the Federal Government, but serving an 
Administration and Congress that can vary with election results, we 
seek to serve the unchanging needs of the Nation, according to the 
priorities of the President and the Congress. The President's 
priorities for the Department range from issues concerning the economy 
to the environment. For example, the President directs the Department 
to promote electronic commerce activities; encourage open and free 
trade; represent American business interests abroad; and assist small 
businesses to expand and create jobs. We are able to address these 
priorities effectively by functioning in accordance with the 
legislation that undergirds our programs and by working closely with 
the President and the committees in Congress, which have programmatic 
and financial oversight for our programs.
The DOC also promotes and expedites American exports, helps nurture 
business contacts abroad, protects U.S. firms from unfair foreign 
competition, and makes how-to-export information accessible to small 
and mid-sized companies throughout the Nation, thereby ensuring that 
U.S. market opportunities span the globe.
The DOC encourages development in every community, clearing the way for 
private-sector growth by building and rebuilding economically deprived 
and distressed communities. We promote minority entrepreneurship to 
establish businesses that frequently anchor neighborhoods and create 
new job opportunities. We work with the private sector to enhance 
competitive assets.
As the Nation looks to revitalize its industries and communities, the 
DOC works as a partner with private entities to build America with an 
eye on the future. Through technology, research and development, and 
innovation, we are making sure America continues to prosper in the 
short-term, while also helping industries prepare for long-term 
success.
The DOC's considerable information capacities help businesses 
understand clearly where our national and world economies are going and 
take advantage of that knowledge by planning the road ahead. Armed with 
the Department's economic and demographic statistics, businesses can 
undertake the new ventures, investments, and expansions that make our 
economy grow.
The DOC has instituted programs and policies that lead to cutting-edge, 
competitive, and better paying jobs. We work every day to boost 
exports, to deregulate business, to help smaller manufacturers battle 
foreign competition, to advance the technologies critical to our future 
prosperity, to invest in our communities, and to fuse economic and 
environmental goals.
The DOC is American business' surest ally in job creation, serving as a 
vital resource base, a tireless advocate, and its Cabinet-level voice.
The Regulatory Plan directly tracks these policy and program 
priorities, only a few of which involve regulation of the private 
sector by the Department.
Responding to the Administration's Regulatory Philosophy and Principles
The vast majority of the Department's programs and activities do not 
involve regulation. Of the Department's 12 primary operating units, 
only two--the Bureau of Industry and Security (BIS) and the National 
Oceanic and Atmospheric Administration (NOAA)--plan significant 
preregulatory or regulatory actions for this Regulatory Plan year. Of 
all the significant actions planned by the Department, NOAA plans to 
complete five actions that rise to the level of ``most important'' of 
the Department's ``significant regulatory actions''. They are (1) 
Amendments 18 and 19 to the Fishery Management Plan for Bering Sea/
Aleutian Islands King and Tanner Crabs - Crab Rationalization Program; 
(2) Designate Critical Habitat for 7 Evolutionarily Significant Units 
(ESUs) of Pacific Salmon and Steelhead in California; (3) Designate 
Critical Habitat for 13 Evolutionarily Significant Units (ESUs) of 
Pacific Salmon and Steelhead in Washington and Oregon;

[[Page 72695]]

(4) Listing Determinations for 27 Evolutionarily Significant Units 
(ESUs) of West Coast Salmon and Oncorhynchus Mykiss; and (5) Northwest 
Hawaiian Islands National Marine Sanctuary; Designation and 
Implementing Regulations. Further information on these actions are 
provided below.
Though not principally a regulatory agency, the DOC has long been a 
leader in advocating and using market-oriented regulatory approaches in 
lieu of traditional command-and-control regulations when such 
approaches offer a better alternative. All regulations are designed and 
implemented to maximize societal benefits while placing the smallest 
possible burden on those being regulated.
The DOC is also refocusing on its regulatory mission by taking into 
account, among other things, the President's regulatory principles. To 
the extent permitted by law, all preregulatory and regulatory 
activities and decisions adhere to the Administration's statement of 
regulatory philosophy and principles, as set forth in section 1 of 
Executive Order 12866. Moreover, we have made bold and dramatic 
changes, never being satisfied with the status quo. We have emphasized, 
initiated, and expanded programs that work in partnership with the 
American people to secure the Nation's economic future. At the same 
time we have downsized, cut regulations, closed offices, and eliminated 
programs and jobs that are not part of our core mission. The bottom 
line is that, after much thought and debate, we have made many hard 
choices needed to make this Department ``state of the art.''
The Secretary has prohibited the issuance of any regulation that 
discriminates on the basis of race, religion, gender, or any other 
suspect category and requires that all regulations be written so as to 
be understandable to those affected by them. The Secretary also 
requires that the Department afford the public the maximum possible 
opportunity to participate in departmental rulemakings, even where 
public participation is not required by law.
National Oceanic and Atmospheric Administration
The National Oceanic and Atmospheric Administration (NOAA) establishes 
and administers Federal policy for the conservation and management of 
the Nation's oceanic, coastal, and atmospheric resources. It provides a 
variety of essential environmental services vital to public safety and 
to the Nation's economy, such as weather forecasts and storm warnings. 
It is a source of objective information on the state of the 
environment. NOAA plays the lead role in achieving the departmental 
goal of promoting stewardship by providing assessments of the global 
environment.
Recognizing that economic growth must go hand-in-hand with 
environmental stewardship, the Department, through NOAA, conducts 
programs designed to provide a better understanding of the connections 
between environmental health, economics, and national security. 
Commerce's emphasis on ``sustainable fisheries'' is saving fisheries 
and confronting short-term economic dislocation, while boosting long-
term economic growth. The Department is where business and 
environmental interests intersect, and the classic debate on the use of 
natural resources is transformed into a ``win-win'' situation for the 
environment and the economy.
Three of NOAA's major components, the National Marine Fisheries 
Services (NMFS), the National Ocean Service (NOS), and the National 
Environmental Satellite, Data, and Information Service (NESDIS), 
exercise regulatory authority.
NMFS oversees the management and conservation of the Nation's marine 
fisheries, protects marine mammals, and promotes economic development 
of the U.S. fishing industry. NOS assists the coastal states in their 
management of land and ocean resources in their coastal zones, 
including estuarine research reserves; manages the Nation's national 
marine sanctuaries; monitors marine pollution; and directs the national 
program for deep-seabed minerals and ocean thermal energy. NESDIS 
administers the civilian weather satellite program and licenses private 
organizations to operate commercial land-remote sensing satellite 
systems.
The Administration is committed to an environmental strategy that 
promotes sustainable economic development and rejects the false choice 
between environmental goals and economic growth. The intent is to have 
the Government's economic decisions guided by a comprehensive 
understanding of the environment. The Department, through NOAA, has a 
unique role in promoting stewardship of the global environment through 
effective management of the Nation's marine and coastal resources and 
in monitoring and predicting changes in the Earth's environment, thus 
linking trade, development, and technology with environmental issues. 
NOAA has the primary Federal responsibility for providing sound 
scientific observations, assessments, and forecasts of environmental 
phenomena on which resource management and other societal decisions can 
be made.
In the environmental stewardship area, NOAA's goals include: rebuilding 
U.S. fisheries by refocusing policies and fishery management planning 
on increased scientific information; increasing the populations of 
depleted, threatened, or endangered species of marine mammals by 
implementing recovery plans that provide for their recovery while still 
allowing for economic and recreational opportunities; promoting healthy 
coastal ecosystems by ensuring that economic development is managed in 
ways that maintain biodiversity and long-term productivity for 
sustained use; and modernizing navigation and positioning services. In 
the environmental assessment and prediction area, goals include: 
modernizing the National Weather Service; implementing reliable 
seasonal and interannual climate forecasts to guide economic planning; 
providing science-based policy advice on options to deal with very 
long-term (decadal to centennial) changes in the environment; and 
advancing and improving short-term warning and forecast services for 
the entire environment.
Magnuson-Stevens Act Rulemakings
Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-
Stevens Act) rulemakings concern the conservation and management of 
fishery resources in the U.S. 3-to-200-mile Exclusive Economic Zone 
(EEZ). Among the several hundred rulemakings that NOAA plans to issue 
in the Regulatory Plan year, a number of the preregulatory and 
regulatory actions will be significant. The exact number of such 
rulemakings is unknown, since they are usually initiated by the actions 
of eight regional Fishery Management Councils (FMCs) that are 
responsible for preparing fishery management plans (FMPs) and FMP 
amendments, and for drafting implementing regulations for each managed 
fishery. Once a rulemaking is triggered by an FMC, the Magnuson-Stevens 
Act places stringent deadlines upon NMFS by which it must exercise its 
rulemaking responsibilities.
While most of these rulemakings will be minor, involving only the 
opening or closing of a fishery under an existing

[[Page 72696]]

FMP, five actions are of particular significance. In the first action 
entitled ``Amendments 18 and 19 to the to the Fishery Management Plan 
for Bering Sea/Aleutian Islands King and Tanner Crabs in the Bering Sea 
and the Aleutian Islands - Crab Rationalization Program,'' NMFS 
proposes to rationalize the Bering Sea and Aleutian Islands crab 
fisheries in the United States Exclusive Economic Zone off Alaska by 
amending the Fishery Management Plan for Bering Sea and Aleutian 
Islands King and Tanner Crabs. The goal of rationalization is to end 
the race for fish and solve the problems of overcapacity while 
providing for a balanced distribution of benefits and improving 
fisheries management and resource conservation. In the second and third 
actions entitled ``Designate Critical Habitat for 7 Evolutionarily 
Significant Units (ESUs) of Pacific Salmon and Steelhead in 
California`'' and ``Designate Critical Habitat for 13 Evolutionarily 
Significant Units (ESUs) of Pacific Salmon and Steelhead in Washington 
and Oregon,'' NMFS would designate critical habitat for 20 Pacific 
salmon and O. mykiss Evolutionarily Significant Units (ECUS) listed 
under the Endangered Species Act of 1973. The geographic areas proposed 
for designation include lakes, riverine, and estuarian habitat in 
Washington, Oregon, Idaho, and California. In addition, in the action 
entitled Listing Determinations for 27 ESUs of West Coast Salmon and 
Oncorhynchus Mykiss, NMFS proposes to list ESUs as endangered or 
threatened, and also to delist ESUs as necessary. Finally, in the 
action entitled Northwest Hawaiian Islands National Marine Sanctuary; 
Designation and Implementation of Regulations, NOAA would designate the 
Northwest Hawaiian Islands as a national marine sanctuary and propose 
implementing regulations that best reflect the goals and objectives of 
the proposed sanctuary.
The Magnuson-Stevens Act, which is the primary legal authority for 
Federal regulation to conserve and manage fishery resources, 
establishes eight regional FMCs, responsible for preparing FMPs and FMP 
amendments. NMFS issues regulations to implement FMPs and FMP 
amendments. FMPs address a variety of fishery matters, including 
depressed stocks, overfished stocks, gear conflicts, and foreign 
fishing. One of the problems that FMPs may address is preventing 
overcapitalization (preventing excess fishing capacity) of fisheries. 
This may be resolved by limiting access to those dependent on the 
fishery in the past and/or by allocating the resource through 
individual transferable quotas, which can be sold on the open market to 
other participants or those wishing access. Quotas set on sound 
scientific information, whether as a total fishing limit for a species 
in a fishery or as a share assigned to each vessel participant, enable 
stressed stocks to rebuild. Other measures include staggering fishing 
seasons or limiting gear types to avoid gear conflicts on the fishing 
grounds, and establishing seasonal and area closures to protect fishery 
stocks.
The FMCs provide a forum for public debate and, using the best 
scientific information available, make the judgments needed to 
determine optimum yield on a fishery-by-fishery basis. Optional 
management measures are examined and selected in accordance with the 
national standards set forth in the Magnuson-Stevens Act. This process, 
including the selection of the preferred management measures, 
constitutes the development, in simplified form, of an FMP. The FMP, 
together with draft implementing regulations and supporting 
documentation, is submitted to NMFS for review against the national 
standards set forth in the Magnuson-Stevens Act, in other provisions of 
the Act, and other applicable laws. The same process applies to 
amending an existing approved FMP.
TheMagnuson-Stevens Act contains ten national standards against which 
fishery management measures are judged. NMFS has supplemented the 
standards with guidelines interpreting each standard, and has updated 
and added to those guidelines. One of the national standards requires 
that management measures, where practicable, minimize costs and avoid 
unnecessary duplication. Under the guidelines, NMFS will not approve 
management measures submitted by an FMC unless the fishery is in need 
of management. Together, the standards and the guidelines correspond to 
many of the Administration's principles of regulation as set forth in 
section 1(b) of Executive Order 12866. One of the national standards 
establishes a qualitative equivalent to the Executive Order's ``net 
benefits'' requirement--one of the focuses of the Administration's 
statement of regulatory philosophy as stated in section 1(a) of the 
Executive order.
Bureau of Industry and Security
The Bureau of Industry and Security (BIS) promotes U.S. national and 
economic security and foreign policy interests by managing and 
enforcing the Department's security-related trade and competitiveness 
programs. BIS plays a key role in challenging issues involving national 
security and nonproliferation, export growth, and high technology. The 
Bureau's continuing major challenge is combating the proliferation of 
weapons of mass destruction while furthering the growth of U.S. 
exports, which are critical to maintaining our leadership in an 
increasingly competitive global economy. BIS strives to be the leading 
innovator in transforming U.S. strategic trade policy and programs to 
adapt to the changing world.
Major Programs and Activities
The Export Administration Regulations (EAR) provide for export controls 
on dual use goods and technology (primarily commercial goods that have 
potential military applications) not only to fight proliferation, but 
also to pursue other national security, short supply, and foreign 
policy goals (such as combating terrorism). Simplifying and updating 
these controls in light of the end of the Cold War has been a major 
accomplishment of BIS.
BIS is also responsible for:
 Enforcing the export control and antiboycott provisionsof the 
            Export Administration Act (EAA), as well as other statutes 
            such as the Fastener Quality Act. The EAA is enforced 
            through a variety of administrative, civil, and criminal 
            sanctions.
 Analyzing and protecting the defense industrial and 
            technologybase, pursuant to the Defense Production Act and 
            other laws. As the Defense Department increases its 
            reliance on dual-use high technology goods as part of its 
            cost-cutting efforts, ensuring that we remain competitive 
            in those sectors and subsectors is critical to our national 
            security.
 Helping Ukraine, Kazakstan, Belarus, Russia, and othernewly 
            emerging countries develop effective export control 
            systems. The effectiveness of U.S. export controls can be 
            severely undercut if ``rogue states'' or terrorists gain 
            access to sensitive goods and technology from other 
            supplier countries.
 Working with former defense plants in the Newly 
            IndependentStates to help make a successful transition to 
            profitable and peaceful civilian endeavors. This involves 
            helping remove unnecessary obstacles to trade and 
            investment and identifying

[[Page 72697]]

            opportunities for joint ventures with U.S. companies.
 Assisting U.S. defense enterprises to meet the challenge of 
            the reduction in defense spending by converting to civilian 
            production and by developing export markets. This work 
            assists in maintaining our defense industrial base as well 
            as preserving jobs for U.S. workers.
_______________________________________________________________________

DOC--National Oceanic and Atmospheric Administration (NOAA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




30. DESIGNATE CRITICAL HABITAT FOR 7 EVOLUTIONARILY SIGNIFICANT UNITS 
(ESUS) OF PACIFIC SALMON AND STEELHEAD IN CALIFORNIA
Priority:


Other Significant


Legal Authority:


16 USC 1533


CFR Citation:


50 CFR 226


Legal Deadline:


NPRM, Judicial, November 30, 2004.


Final, Judicial, June 15, 2005.


Abstract:


This action would designate critical habitat for 7 Pacific salmon and 
O. mykiss Evolutionarily Significant Units (ESUs) listed under the 
Endangered Species Act of 1973. The geographic area proposed for 
designation include riverine and estuarine habitat in California.


Statement of Need:


On February 16, 2000, NMFS published final critical habitat 
designations for 19 ESUs, thereby completing designations for all 25 
ESUs listed at the time. In considering the economic impact of the 
February 16, 2000, action, NMFS determined that the critical habitat 
designations would impose very little or no additional requirements on 
Federal agencies beyond those already associated with the listing of 
the species themselves. The National Association of Homebuilders (NAHB) 
challenged the designations in District Court in Washington, D.C. as 
having inadequately considered the economic impacts of the critical 
habitat designations (National Association of Homebuilders v. Evans, 
2002 WL 1205743 No. 00-CV-2799 (D.D.C.)). As a result of a district 
court's approval of a consent decree, the 19 critical habitat 
designations were vacated. A subsequent complaint from a group of 
fishing and environmental organizations regarding our failure to 
designate critical habitat led to a court approved agreement (July 13, 
2004) to designate critical habitat for any listed ESUs under the 
Northwest Region's responsibility by September 30, 2004, and for any 
listed ESUs under the Southwest Region's responsibility by November 30, 
2004. Final critical habitat designations for all of these ESUs are due 
on June 15, 2005.


Summary of Legal Basis:


Sections 4(a)(3)(A) and 4(b)(6)(C)(ii) of the Endangered Species Act 
(ESA) require the Secretary to designate critical habitat concurrently 
with making a determination that a species is threatened or endangered. 
Section 4(b)(6)(C)(ii) requires that a final regulation designating 
critical habitat be published concurrently with the final regulation 
listing the species as threatened or endangered unless such habitat is 
not then determinable, in which case, the Secretary may extend the one-
year period for finalizing critical habitat by one additional year. The 
court approved agreement mentioned in the first paragraph requires 
final critical habitat designations by June 15, 2005, concurrently with 
the deadline for final listing determinations on the 26 ESUs that were 
proposed for revised listing determinations and the one additional ESU 
that was proposed for listing.


Section 4(b)(2) requires that critical habitat designation be based on 
the best scientific data available after taking economic impacts, 
impacts on national security, and any other relevant impact of 
specifying any particular area as critical habitat into account. The 
Secretary may exclude any area from critical habitat if he determines 
that the benefits of such exclusion outweigh the benefits of specifying 
such area as part of the critical habitat, unless failure to designate 
such area as critical habitat will result in the extinction of the 
species concerned.


Alternatives:


Critical habitat designation is a requirement under the ESA. 
Alternatives can be considered during the section 4(b)(2) analysis when 
NMFS weighs the benefits of excluding some critical habitat with the 
benefits of specifying it as critical habitat. NMFS ranked different 
critical habitat areas as high, medium, or low value in terms of the 
benefits that can be expected to accrue to the salmon ESUs. One 
alternative is to include all habitat that has been identified as 
critical in the critical habitat designation. Another alternative is to 
exclude all the low value areas from the designation. A third 
alternative is to exclude a combination of all low value areas and some 
medium value areas.


Anticipated Cost and Benefits:


NMFS has conducted an economic analysis on the proposal to designate 
critical habitat for the ESUs in the Region. The net economic impacts 
of ESA section 7 associated with the areas proposed for designation are 
estimated to be approximately $88,980,000. The benefits to Pacific 
salmon cannot be monetized easily, but critical habitat designation 
should contribute to the health of the species.


Risks:


The principal benefit of designating critical habitat is that Federal 
activities that may affect such habitat are subject to consultation 
pursuant to section 7 of the ESA. Such consultation requires every 
Federal agency to insure that any action it authorizes, funds or 
carries out is not likely to result in the destruction or adverse 
modification of critical habitat. This complements the section 7 
provision that Federal agencies insure that their action is not likely 
to jeopardize the continued existence of a listed species. Another 
benefit is that the designation of critical habitat can serve to 
educate the public regarding the potential conservation value of an 
area. This may focus and contribute to conservation efforts by clearly 
delineating areas of high conservation value for certain species.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            65 FR 79328                                    12/19/00
NPRM Comment Period End                                        02/20/01
NPRM                                                           11/00/04
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses, Governmental Jurisdictions


Government Levels Affected:


None

[[Page 72698]]

Agency Contact:
James H. Lecky
Assistant Regional Administrator, Southwest Region
Department of Commerce
National Oceanic and Atmospheric Administration
501 W. Ocean Blvd. No. 4200
Long Beach, CA 90802
Phone: 502 980-4015
Fax: 502 980-4027
Related RIN: Related to 0648-AQ77
RIN: 0648-AO04
_______________________________________________________________________

DOC--NOAA



31. DESIGNATE CRITICAL HABITAT FOR 13 EVOLUTIONARILY SIGNIFICANT UNITS 
(ESUS) OF PACIFIC SALMON AND STEELHEAD IN WASHINGTON, OREGON AND IDAHO
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


16 USC 1533


CFR Citation:


50 CFR 226; 50 CFR 424


Legal Deadline:


NPRM, Judicial, September 30, 2004.


Final, Judicial, June 15, 2005.


Abstract:


This action would designate critical habitat for 13 Pacific salmon and 
O. mykiss Evolutionarily Significant Units (ESUs) listed under the 
Endangered Species Act of 1973. The geographic areas proposed for 
designation include lakes, riverine, and estuarine habitat in 
Washington, Oregon, and Idaho, and marine nearshore habitat in 
Washington.


Statement of Need:


On February 16, 2000, NMFS published final critical habitat 
designations for 19 ESUs, thereby completing designations for all 25 
ESUs listed at the time. In considering the economic impact of the 
February 16, 2000, action, NMFS determined that the critical habitat 
designations would impose very little or no additional requirements on 
Federal agencies beyond those already associated with the listing of 
the species themselves. The National Association of Homebuilders (NAHB) 
challenged the designations in District Court in Washington, D.C. as 
having inadequately considered the economic impacts of the critical 
habitat designations (National Association of Homebuilders v. Evans, 
2002 WL 1205743 No. 00-CV-2799 (D.D.C.)). As a result of a district 
court's approval of a consent decree, the 19 critical habitat 
designations were vacated. A subsequent complaint from a group of 
fishing and environmental organizations regarding our failure to 
designate critical habitat led to a court approved agreement (July 13, 
2004) to designate critical habitat for any listed ESUs under the 
Northwest Region's responsibility by September 30, 2004, and for any 
listed ESUs under the Southwest Region's responsibility by November 30, 
2004. Final critical habitat designations for all of these ESUs are due 
on June 15, 2005.


Summary of Legal Basis:


Sections 4(a)(3)(A) and 4(b)(6)(C)(ii) of the Endangered Species Act 
(ESA) require the Secretary to designate critical habitat concurrently 
with making a determination that a species is threatened or endangered. 
Section 4(b)(6)(C)(ii) requires that a final regulation designating 
critical habitat be published concurrently with the final regulation 
listing the species as threatened or endangered unless such habitat is 
not then determinable, in which case, the Secretary may extend the one-
year period for finalizing critical habitat by one additional year. The 
court approved agreement mentioned in the first paragraph requires 
final critical habitat designations by June 15, 2005, concurrently with 
the deadline for final listing determinations on the 26 ESUs that were 
proposed for revised listing determinations and the one additional ESU 
that was proposed for listing.


Section 4(b)(2) requires that critical habitat designation be based on 
the best scientific data available after taking economic impacts, 
impacts on national security, and any other relevant impact of 
specifying any particular area as critical habitat into account. The 
Secretary may exclude any area from critical habitat if he determines 
that the benefits of such exclusion outweigh the benefits of specifying 
such area as part of the critical habitat, unless failure to designate 
such area as critical habitat will result in the extinction of the 
species concerned.


Alternatives:


Critical habitat designation is a requirement under the ESA. 
Alternatives can be considered during the section 4(b)(2) analysis when 
NMFS weighs the benefits of excluding some critical habitat with the 
benefits of specifying it as critical habitat. NMFS has ranked 
different critical habitat areas as high, medium, or low value in terms 
of the benefits that can be expected to accrue to the salmon ESUs. One 
alternative is to include all habitat that has been identified as 
critical in the critical habitat designation. Another alternative is to 
exclude all the low value areas from the designation. A third 
alternative is to exclude a combination of all low value areas and some 
medium value areas.


Anticipated Cost and Benefits:


NMFS has conducted an economic analysis on the proposal to designate 
critical habitat for the ESUs in the Northwest Region. The net economic 
impacts of ESA section 7 associated with the areas proposed for 
designation are estimated to be approximately $223,950,127. The 
benefits to Pacific salmon cannot be monetized easily, but critical 
habitat designation should contribute to the health of the species.


Risks:


The principal benefit of designating critical habitat is that Federal 
activities that may affect such habitat are subject to consultation 
pursuant to section 7 of the ESA. Such consultation requires every 
Federal agency to insure that any action it authorizes, funds or 
carries out is not likely to result in the destruction or adverse 
modification of critical habitat. This complements the section 7 
provision that Federal agencies insure that their action is not likely 
to jeopardize the continued existence of a listed species. Another 
benefit is that the designation of critical habitat can serve to 
educate the public regarding the potential conservation value of an 
area. This may focus and contribute to conservation efforts by clearly 
delineating areas of high conservation value for certain species.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           68 FR 55926                                    09/29/03
ANPRM Comment Period End                                       11/13/03
NPRM                                                           11/00/04
NPRM Comment Period End                                        02/00/05
Final Action                                                   06/00/05
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses, Governmental Jurisdictions

[[Page 72699]]

Government Levels Affected:


Local, State, Tribal


Agency Contact:
D. Robert Lohn
Regional Administrator, Northwest Region, NMFS
Department of Commerce
National Oceanic and Atmospheric Administration
7600 Sand Point Way NE, Building 1
Seattle, WA 48115-0070
Phone: 206 526-6150
Fax: 206 526-6426
RIN: 0648-AQ77
_______________________________________________________________________

DOC--NOAA



32.  AMENDMENTS 18 AND 19 TO THE FISHERY MANAGEMENT PLAN FOR 
BERING SEA/ALEUTIAN ISLANDS KING AND TANNER CRABS--CRAB RATIONALIZATION 
PROGRAM
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


16 USC 1801


CFR Citation:


50 CFR 679; 50 CFR 680


Legal Deadline:


Other, Statutory, January 1, 2005, Secretary approval of statutorily 
mandated FMP Amendment.


Abstract:


This action would rationalize the Bering Sea and Aleutian Islands crab 
fisheries in the United States Exclusive Economic Zone off Alaska by 
amending the Fishery Management Plan for Bering Sea and Aleutian 
Islands King and Tanner Crabs. The goal of rationalization is to end 
the race for fish and solve the problems of overcapacity while 
providing for a balanced distribution of benefits and improving 
fisheries management and resource conservation.


Statement of Need:


This action would amend the regulations to implement Amendments 18 and 
19 of the Fishery Management Plan for Bering Sea/Aleutian Islands King 
and Tanner Crabs in Waters off Alaska. The U.S. Congress amended the 
Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-
Stevens) to require the Secretary of Commerce to approve the Crab 
Rationalization Program (Program) by January 1, 2005. Amendments 18 and 
19 to the Fishery Management Plan for Bering Sea/Aleutian Islands King 
and Tanner Crabs (FMP) constitute this program. The regulations in this 
action are needed to implement this program. This rule is necessary to 
increase resource conservation, improve economic efficiency, and to 
address social concerns. This action is intended to promote the goals 
and objectives of the Magnuson-Stevens Act, the FMP, and other 
applicable laws.


Summary of Legal Basis:


In January 2004, the U.S. Congress amended section 313 of the Magnuson-
Stevens Act through the Consolidated Appropriations Act of 2004 (Pub. 
L. No. 108-199, section 801), by adding paragraph (j). As amended, 
section 313(j)(1) requires the Secretary to approve and implement, by 
January 1, 2005, the Voluntary Three-pie Cooperative Program (Program) 
as it was approved by the North Pacific Fishery Management Council 
(Council) between June 2002 and April 2003, and all trailing amendments 
including those reported to Congress on May 6, 2003.


At this time, NMFS has not determined that the FMP amendments that this 
rule would implement are consistent with the national standards of the 
Magnuson-Stevens Act and other applicable laws. NMFS, in making that 
determination, will take into account the data, views, and comments 
received during the comment period.


Alternatives:


The Environmental Impact Statement (EIS) presents four alternative 
programs for management of the BSAI crab fisheries, namely, Status Quo/
No Action (Alternative 1); a Voluntary Three-pie Cooperative Program 
(Alternative 2); an Individual Fisherman's Quota (IFQ) Program 
(Alternative 3); and a Cooperative Program (alternative 4). These 
alternatives constitute the suite of ``significant alternatives,'' 
under this action, for Regulatory Flexibility Act purposes. Please 
refer to EIS and Regulatory Impact Review (RIR) for more details.


Anticipated Cost and Benefits:


It is probable that producers will experience a net benefit as a result 
of implementing quota and cooperative features of the Program. The 
fishing industry operating in the BSAI crab fishery may see an economic 
increase from the implementation of the Program by lengthening the 
interval of time that crab are supplied to the market. Other 
rationalized fisheries have been observed to generate higher market 
prices by allowing for a longer interval of time during a year to 
supply product to the marketplace. In addition, it is likely that the 
costs to crab fishing and processing operations will be substantially 
reduced as a result of the quota and cooperative features of the 
Program. The BSAI crab fisheries are among the most highly 
overcapitalized fisheries in the Alaska region. Participation in the 
current short and inefficient open access fishing season has resulted 
in a greater number of fishing vessels, higher vessel operating costs, 
a greater number of crew, and costly redundancies in processing 
capacity compared with what will be required as a result of the quota 
and cooperative elements of the Program.


It is unknown how this regulation would affect consumers. There is the 
potential that consumers will benefit from less seasonal crab supplies. 
It is probable that a less rapidly paced fishery may result in improved 
product quality at harvest. Handling damage from the compressed 
seasons, symptomatic of the present managed open access crab fisheries 
may be significantly reduced by longer seasons under the quota 
fisheries, where vessels have expanded choices of how often and what 
times of year to fish.


Due to the lack of data on fixed and variable costs for both the BSAI 
crab fishery and processing operations, and inadequate data on market 
prices by crab product quality and product form, it is not possible to 
estimate the magnitude of the qualitative changes to the industry or 
nation from the Program. After the Program is implemented, the official 
record of quota market transactions and a mandatory economic data 
collection program will allow for detailed quantitative estimates of 
benefits and costs.


Risks:


The Program is a limited access system that balances the interests of 
several groups who depend on these fisheries. The Program addresses 
conservation and management issues associated with the current derby 
fishery and would reduce bycatch and associated discard mortality. The 
Program also would increase the safety of crab fishermen by ending the 
race for fish. Share allocations to harvesters and processors, together 
with incentives to participate in fishery cooperatives, would increase 
efficiencies, provide economic stability, and facilitate

[[Page 72700]]

compensated reduction of excess capacities in the harvesting and 
processing sectors. Community interests would be protected by Community 
Development Quota (CDQ) allocations and regional landing and processing 
requirements, as well as by several community protection measures.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Notice          69 FR 53359                                    09/01/04
NPRM            69 FR 63200                                    10/29/04
NPRM Comment Period End                                        12/13/04
Final Action                                                   02/00/05
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses, Governmental Jurisdictions, Organizations


Government Levels Affected:


Federal, Local, State


Agency Contact:
James W. Balsiger
Administrator, Alaska Region
Department of Commerce
National Oceanic and Atmospheric Administration
NMFS
P.O. 21668
Juneau, AK 99802
Phone: 907 586-7221
Fax: 907 586-7249
RIN: 0648-AS47
_______________________________________________________________________

DOC--NOAA



33.  NORTHWEST HAWAIIAN ISLANDS NATIONAL MARINE SANCTUARY; 
DESIGNATION AND IMPLEMENTATION OF REGULATIONS
Priority:


Other Significant


Legal Authority:


PL 106-513; 16 USC 1431 et seq


CFR Citation:


Not Yet Determined


Legal Deadline:


None


Abstract:


The National Marine Sanctuaries Program, together with state and 
federal partners and other stakeholders, designate the Northwest 
Hawaiian Islands as a national marine sanctuary and implement 
regulations that best reflects the goals and objectives of the proposed 
sanctuary.


Statement of Need:


By designating the Northwest Hawaiian Islands (NWHI) as a national 
marine sanctuary, the National Marine Sanctuary Program (NMSP), 
together with state and federal partners and other stakeholders, hope 
to catalyze the collaborative development of an ecosystem approach to 
address management issues. The NWHI are among the few, large-scale, 
intact, predator-dominated coral reef ecosystems left in the world. 
Significant Native Hawaiian cultural and maritime historical resources 
are found throughout the region. These vast and remote coral reef 
ecosystems support a distinctive assemblage of marine mammals, fish, 
sea turtles, birds, and invertebrates, including species that are 
endemic, rare, threatened, or endangered. Unfortunately, coral reef 
systems like the NWHI are in a state of decline as direct or indirect 
result of human activities.


Fishing is one of many human activities that may have direct and 
indirect effects on the health and integrity of coral reef ecosystems. 
Some of the direct impacts of fishing on coral reef ecosystems include 
depletion of fish stocks and habitat degradation. Examples of indirect 
effects include shifts in community structure and predatory-prey 
relationships. Historically, fisheries management approaches have been 
conducted through a single species approach. While this fishery 
management approach can provide valuable information, it does not 
consider the broader impacts of the activity on an ecosystem. The NMSP 
and the National Oceanic and Atmospheric Administration (NOAA) as a 
whole are working toward an ecosystem approach to resource management. 
This form of management is adaptive, is geographically specified, takes 
account of ecosystem knowledge and uncertainties, considers multiple 
external influences, and strives to balance diverse social objectives. 
Fishing in the NWHI must be carefully considered and evaluated in the 
context of an ecosystem approach to management in order to achieve a 
healthy, functional, and resilient ecosystem.


Summary of Legal Basis:


The NMSP of NOAA is in the process of designating the Northwest 
Hawaiian Islands Coral Reef Ecosystem Reserve (Reserve) as a national 
marine sanctuary as directed by the National Marine Sanctuaries 
Amendments Act (NMSAA) of 2000 and Executive Orders 13178 and 13196, 
and in accordance with the National Marine Sanctuaries Act (NMSA). The 
Reserve was established in 2000 by EO 13178 with the principal purpose 
of long-term conservation and protection of the coral reef ecosystem 
and related marine resources and species of the Northwest Hawaiian 
Islands (NWHI) in their natural character. The sanctuary designation 
process is described in Section 304 of the NMSA and requires the 
preparation of an environmental impact statement.


Alternatives:


The NMSP is considering seven alternatives. The first alternative 
(Status Quo/No Action Alternative) maintains the NWHI Research and EO 
provisions as is. It assumes a sanctuary will not be designated. This 
places caps on all fishing activities that were active at the time the 
EO was issued, and prohibits the development of new or inactive 
fisheries. This alternative makes provisions for several types of 
commercial and recreational fishing including bottomfishing/pelagic 
trolling, commercial trolling, sustenance fishing, and Native Hawaiian 
cultural and subsistence use. The second alternative mirrors the 
provisions of EO 13178 and 13196 but assumes those provisions will 
become regulations promulgated under the NMSA. In addition, this 
alternative provides straight-line boundaries, as opposed to fathom 
boundaries, to define Reserve/Sanctuary Preservation Areas to aid in 
user compliance and enforcement. Fishing regulations would be 
promulgated that would prohibit precious coral and crustacean harvest, 
but provide for bottomfish/pelagic trolling, commercial pelagic 
trolling, various forms of recreational fishing, and Native Hawaiian 
cultural and subsistence uses. The third alternative was developed by 
the Western Pacific Fishery Management Council and assumes that the 
Reserve would be designated as a national marine sanctuary, with 
fishing regulations promulgated under the NMSA. However, fishing 
activities would be managed in accordance with existing fishery 
management plans for those fishing activities currently practiced. This 
alternative also suggests that future harvest of precious corals and 
crustaceans would be managed under previously developed FMPs. However, 
in a Federal Register notice, NOAA issues a zero-harvest guideline and

[[Page 72701]]

cited the EO as a reason to continue closure of the crustacean fishery.


The fourth alternative establishes a sanctuary with fishing regulations 
that would protect the highest ecosystem values while allowing 
compatible fishing activities in areas where they are likely to have 
less impact on the ecosystem. It prohibits precious coral and 
crustacean harvest, and pelagic longlining, but provides for commercial 
bottomfish/pelagic trolling, commercial pelagic trolling, various forms 
of recreational fishing, and Native Hawaiian cultural and subsistence 
uses through a permitting process. The fifth alternative is an 
iteration of the fourth alternative and prohibits the same fishing 
activities. It also provides for bottomfish/pelagic trolling, 
commercial pelagic trolling, various forms of recreational fishing and 
Native Hawaiian cultural subsistence uses. The sixth alternative was 
developed by the Reserve Advisory Council and is similar to alternative 
2 but would close bottomfish/pelagic trolling within 1 year of 
sanctuary designation. It also calls for a zoning system to limit 
commercial and recreational pelagic fishing to minimize interactions 
with protected wildlife. The seventh alternative closes immediately the 
entire area to all extractive use, except for research or education.


Anticipated Cost and Benefits:


There are currently nine active commercial bottomfishermen in the NWHI, 
five in the Mau zone and four in the Ho'omalu zone. Total reported 2003 
gross revenue for the nine NWHI fishermen was just under $1.3 million 
with $611 thousand for the Mau zone and $674 thousand for the Ho'omalu 
zone. Total costs for 2003 were estimated at $974 thousand for the nine 
NWHI fishermen. The first alternative (Status Quo/No Action 
Alternative) would result in a 28 percent reduction in pounds landed 
for bottomfish/pelagic trolling catch, and 13 percent reduction for 
pelagic species compared to pre-EO levels based on full implementation 
of the EO. The second alternative would result in a 28 percent 
reduction in pounds landed for bottomfish/ pelagic trolling catch, and 
13 percent reduction in the pelagic catch associated with 
bottomfishing, as compared to pre-EO levels. The third alternative 
would result in a 0 percent reduction in pounds landed. The fourth 
alternative would reduce commercial bottomfish catch by 24 percent and 
pelagic landings by 13 percent. The fifth alternative would reduce 
bottomfish catch by 62 percent and pelagic catch by 10 percent due to 
the phase-out of bottomfishing for the Ho'omalu zone. The sixth 
alternative contemplates the complete phase-out of this industry within 
one year and would impact the industry by 100 percent. The seventh 
alternative would close the entire region to extractive use and would 
impact the industry by 100 percent.


Risks:


The establishment of the NWHI as a national marine sanctuary would 
protect one of the world's most productive and biologically rich 
ecosystems on Earth. The NWHI are among the few, large-scale, intact, 
predator-dominated coral reef ecosystems left in the world. Significant 
Native Hawaiian cultural and maritime historical resources are found 
throughout the region. These vast and remote coral reef ecosystems 
support a distinctive assemblage of marine mammals, fish, sea turtles, 
birds, and invertebrate, including species that are endemic, rare, 
threatened, or endangered. Federally protected species include the 
endangered Hawaiian monk seal. Roughly one-quarter of the 7,000 species 
found in the NWHI are believed to be endemic to the Hawaiian Island 
chain, found nowhere else on Earth.


Almost all of the alternatives would continue to allow some level of 
human activity in the area, including fishing. Research, monitoring and 
education activities would also be allowed pursuant to a permit system. 
There would, therefore, be risks to human safety associated with 
fishing and other vessels operating in remote areas of the Hawaiian 
Islands. At times, vessels could be exposed to potentially serious 
weather and sea conditions that could result in loss of life or injury 
as well as loss of property. In addition, risks to the environment 
could result from vessel groundings, lost fishing gear and other 
equipment, fuel spills, unauthorized discharges including sewage, etc. 
Depending on location, any of these incidents could harm or destroy 
fragile coral reefs or marine life.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           04/00/05
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Federal, Local, State


Federalism:


 This action may have federalism implications as defined in EO 13132.


Agency Contact:
Ted Beuttler
Department of Commerce
National Oceanic and Atmospheric Administration
SSMC4
Room 6111
East-West Highway
Silver Spring, MD 20910
Phone: 301 713-2967
Email: [email protected]
RIN: 0648-AS83
_______________________________________________________________________

DOC--NOAA

                              -----------

                            FINAL RULE STAGE

                              -----------




34. LISTING DETERMINATIONS FOR 27 EVOLUTIONARILY SIGNIFICANT UNITS 
(ESUS) OF WEST COAST SALMON AND ONCORHYNCHUS MYKISS
Priority:


Other Significant


Legal Authority:


16 USC 1533


CFR Citation:


50 CFR 223; 50 CFR 224


Legal Deadline:


NPRM, Judicial, March 31, 2004.


NMFS has requested an extension to the court-ordered deadline, but no 
decision has been made as of 4/23/2004.


Abstract:


NMFS has completed status reviews for 26 West Coast salmon and O. 
mykiss (inclusive of anadromous steelhead and co-occurring resident 
rainbow trout) Evolutionarily Significant Units (ESUs) previously 
listed as threatened and endangered species under the ESA, as well as 
one ESU that was designated as a candidate species. Following a 
September 2001 U.S. District Court ruling that rejected how NMFS treats 
hatchery populations in its listing determinations, the agency received 
several petitions seeking to delist, or to redefine and list several 
ESUs on the basis of the Court's ruling. In response to these petitions 
NMFS initiated status

[[Page 72702]]

reviews for 16 ESUs, and elected to conduct status reviews for an 
additional 11 ESUs. Based on these reviews, NMFS is taking this action 
to list ESUs as endangered or threatened, and also to delist ESUs as 
necessary.


Statement of Need:


In September 2001, the U.S. District Court in Eugene, Oregon, in Alsea 
Valley Alliance v. Evans (161 F. Supp. 2d 1154, D. Oreg. 2001; Alsea 
decision), set aside NMFS' 1998 ESA listing of Oregon Coast coho salmon 
(63 FR 42587; 08/10/1998). The Court ruled that the ESA does not allow 
NMFS to list a subset of an ESU, and that NMFS had improperly excluded 
stocks from the listing once it had decided that certain hatchery 
stocks were part of the ESU. Although the Court's ruling affected only 
one ESU, the interpretive issue raised by the ruling called into 
question nearly all of NMFS' Pacific salmonid listing determinations. 
The Court struck down the 1998 final rule listing Oregon coast coho as 
a threatened species, thus removing the ESU from the protections of the 
ESA. The Court remanded the case to NMFS for reconsideration consistent 
with the Alsea decision. NMFS did not contest the Court's ruling and 
informed the Court it would comply. In November 2001, intervenors 
appealed the Court's ruling to the U.S. Ninth Circuit Court of Appeals. 
Pending resolution of the appeal, the Ninth Circuit stayed the District 
Court's remand order and invalidation of the 1998 listing. While the 
stay was in place, the Oregon Coast coho ESU was again afforded the 
protections of the ESA (Alsea Valley Alliance v. Evans, 9th Circuit 
appeal, No. 01-36071, December 14, 2001). On February 24, 2004, the 
Appeals Court dismissed the appeal, and dissolved its stay of the 
District Courts' ruling in Alsea.


Following the District Court's ruling in the Alsea case, NMFS received 
several petitions (summarized below) addressing 17 listed salmonid 
ESUs, including five steelhead ESUs. These petitions cited the Alsea 
ruling and focused on NMFS' past practice of excluding certain ESU 
hatchery stocks from listing protection. Various litigants have also 
challenged the failure to list resident populations included in 
threatened and endangered steelhead ESUs. The anadromous form of O. 
mykiss is presently under NMFS' jurisdiction, while the resident 
freshwater forms, usually called ``rainbow'' or ``redband'' trout, are 
under FWS jurisdiction. In Environmental Defense Center et al. v. Evans 
et al. (EDC v. Evans, SACV-00-1212-AHS (EEA)), the plaintiffs argue 
that NMFS failed to include resident populations in the endangered 
listing of the Southern California steelhead ESU (62 FR 43937; August 
18, 1997). In Modesto Irrigation District et al. v. Evans et al. (MID 
v. Evans, CIV-F-02-6553 OWW DLB (E.D.Cal)), the plaintiffs seek to 
invalidate NMFS' 1997 threatened listing of the Central Valley 
California steelhead ESU (63 FR 13347; March 19, 1998) for failing to 
list hatchery and resident populations identified as part of the ESU. 
This same factual situation is found in all listed steelhead ESUs; the 
listings do not include hatchery and/or resident populations considered 
to be part of the ESUs. For the proposed listing determinations 
detailed in this rule to be compliant with the Court's ruling in the 
Alsea case, all populations or stocks (natural, hatchery, resident, 
etc.) included in an ESU must be listed if it is determined that the 
ESU is threatened or endangered under the ESA.


Although the ESA section 4(d) regulations for threatened salmonids have 
proven effective at appropriately protecting threatened salmonid ESUs 
and permitting certain activities, several of the limits described 
therein are redundant, outdated, or are located disjunctly in the Code 
of Federal Regulations (CFR). The resulting complexity of the existing 
4(d) regulations unnecessarily increases the administrative and 
regulatory burden of managing protective regulations for threatened 
ESUs, and does not effectively convey to the public the specific ESUs 
for which certain activities may be exempted from the take prohibitions 
under 4(d). As part of this proposed rulemaking, NMFS proposes to 
clarify the existing section 4(d) regulations for threatened salmonids 
so that they can be more efficiently and effectively accessed and 
interpreted by all affected parties.


Summary of Legal Basis:


Following the ruling in the Alsea case, NMFS received several petitions 
seeking to delist, or to redefine and list, ESUs of Pacific salmon and 
steelhead. The petitioners made reference to the Alsea decision in 
arguing for NMFS to reconsider the listing status for certain ESUs. 
Between September 2001 and April 2002, NMFS received eight separate 
petitions addressing a total of 17 listed salmon and steelhead ESUs. 
The ESA requires that, as a consequence of accepting the above 
petitions, NMFS promptly commence a review of the species' status and 
make a finding within 12 months after receiving the petition, whether 
the petitioned action is warranted (ESA section 4(b)(3)). There are 16 
ESUs for which NMFS has statutory deadlines for the completion of ESA 
status reviews and listing determinations: seven chinook ESUs (the 
Upper Willamette River, Lower Columbia River, Upper Columbia River 
spring-run, Puget Sound, Snake River fall-run, and Snake River spring/
summer-run chinook ESUs); three coho ESUs (the Central California 
Coast, Southern Oregon/Northern California Coast, and Oregon Coast coho 
ESUs); two chum ESUs (the Columbia River and Hood Canal summer-run chum 
salmon ESUs); and five steelhead ESUs (the Upper Willamette River, 
Lower Columbia River, Middle Columbia River, Upper Columbia River, and 
Snake River Basin steelhead ESUs).


Alternatives:


NMFS is required to use the best available scientific and commercial 
information in making its listing determinations under the ESA. Listing 
determinations are not subject to National Environmental Policy Act 
analysis, and they are exempt from economic considerations. This rule 
would clarify the existing section 4(d) regulations, and thus, NMFS is 
not evaluating new alternatives.


Anticipated Cost and Benefits:


This action would largely preserve the existing regulatory regime. 
Currently, hatchery fish are not listed, so their take is not 
prohibited. The provisions in this action would allow hatchery fish to 
continue to be available for harvest by not prohibiting their take. 
Currently, for the two species listed as endangered, all take is 
prohibited by section 9(a) of the ESA. The provisions in this action 
would maintain take prohibitions but with the greater flexibility 
allowed by a section 4(d) rule. Currently, the species listed as 
threatened are covered under a mix of 4(d) rules with varying degrees 
of flexibility. This rule would consolidate all of the species under 
one rule and apply the set of prohibitions and exceptions NMFS has 
found most flexible. For one species, Columbia River Coho, this rule 
would impose take prohibitions where none previously existed. NMFS has 
concluded that this revision will not have significant impacts on small 
entities. Since take of hatchery fish will not be prohibited, fisheries 
will be largely unaffected. Landowners will not

[[Page 72703]]

be affected because the range of the newly listed coho ESU overlaps 
that of already-listed species whose take is already prohibited.


Risks:


NMFS' Pacific Salmonid Biological Review Team (BRT) (an expert panel of 
scientists from several federal agencies including NMFS, FWS, and the 
U.S. Geological Survey) reviewed the viability and extinction risk of 
naturally spawning populations in the 27 ESUs that are the subject of 
this proposed rule (NMFS, 2003b). The BRT evaluated the risk of 
extinction based on the performance of the naturally spawning 
populations in each of the ESUs under the assumption that present 
conditions will continue into the future. The BRT did not explicitly 
consider artificial propagation in its evaluations. The BRT assessed 
ESU-level extinction risk (as indicated by the viability of the 
naturally spawning populations) at two levels: first, at the simpler 
population level; then, at the overall ESU level. The BRT used criteria 
for `Viable Salmonid Populations' (VSP; McElhany et al., 2000) to guide 
its risk assessments. The VSP criteria were developed to provide a 
consistent and logical reference for making viability determinations 
and are based on are view and synthesis of the conservation biology and 
salmon literature. Individual populations were evaluated according to 
the four VSP criteria: Abundance, growth rate/productivity, spatial 
structure, and diversity. These four parameters are universal 
indicators of species viability, and individually and collectively 
function as reasonable predictors of extinction risk. After reviewing 
all relevant biological information for the populations in a particular 
ESU, the BRT ascribed an ESU-level risk score for each of the four VSP 
criteria.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            69 FR 33102                                    06/14/04
NPRM Comment Period End                                        09/13/04
NPRM            69 FR 53031                                    08/31/04
NPRM Comment Period Extended to                                10/20/04
Final Action                                                   06/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, Local, State, Tribal


Agency Contact:
Laurie K. Allen
Acting Director
Department of Commerce
National Oceanic and Atmospheric Administration
Office of Protected Resources
1315 East-West Highway
Silver Spring, MD 20912
Phone: 301 713-2332
RIN: 0648-AR93
BILLING CODE 3510-BW-S

[[Page 72704]]


DEPARTMENT OF DEFENSE (DOD)



Statement of Regulatory Priorities
Background
 The Department of Defense (DoD) is the largest Federal department 
consisting of 3 military departments (Army, Navy, and Air Force), 9 
unified combatant commands, 16 Defense agencies, and 11 DoD field 
activities. It has over 1,400,000 military personnel and 675,000 
civilians assigned as of July 31, 2004, and over 200 large and medium 
installations in the continental United States, U. S. territories, and 
foreign countries. The overall size, composition, and dispersion of the 
Department of Defense, coupled with an innovative regulatory program, 
presents a challenge to the management of the Defense regulatory 
efforts under Executive Order 12866 ``Regulatory Planning and Review'' 
of September 30, 1993.
 Because of its diversified nature, DoD is affected by the regulations 
issued by regulatory agencies such as the Departments of Energy, Health 
and Human Services, Housing and Urban Development, Labor, 
Transportation, and the Environmental Protection Agency. In order to 
develop the best possible regulations that embody the principles and 
objectives embedded in Executive Order 12866, there must be 
coordination of proposed regulations among the regulating agencies and 
the affected Defense components. Coordinating the proposed regulations 
in advance throughout an organization as large as DoD is 
straightforward, yet a formidable undertaking.
 DoD is not a regulatory agency but occasionally issues regulations 
that have an impact on the public. These regulations, while small in 
number compared to the regulating agencies, can be significant as 
defined in Executive Order 12866. In addition, some of DoD's 
regulations may affect the regulatory agencies. DoD, as an integral 
part of its program, not only receives coordinating actions from the 
regulating agencies, but coordinates with the agencies that are 
impacted by its regulations as well.
 The regulatory program within DoD fully incorporates the provisions of 
the President's priorities and objectives under Executive Order 12866. 
Promulgating and implementing the regulatory program throughout DoD 
presents a unique challenge to the management of our regulatory 
efforts.
Coordination
Interagency
 DoD annually receives regulatory plans from those agencies that impact 
the operation of the Department through the issuance of regulations. A 
system for coordinating the review process is in place, regulations are 
reviewed, and comments are forwarded to the Office of Management and 
Budget. The system is working in the Department, and the feedback from 
the Defense components is most encouraging, since they are able to see 
and comment on regulations from the other agencies before they are 
required to comply with them. The coordination process in DoD continues 
to work as outlined in Executive Order 12866.
Internal
 Through regulatory program points of contact in the Department, we 
have established a system that provides information from the 
Administrator of the Office of Information and Regulatory Affairs 
(OIRA) to the personnel responsible for the development and 
implementation of DoD regulations. Conversely, the system can provide 
feedback from DoD regulatory personnel to the Administrator, OIRA. DoD 
continues to refine its internal procedures, and this ongoing effort to 
improve coordination and communication practices is well received and 
supported within the Department.
Overall Priorities
 The Department of Defense needs to function at a reasonable cost, 
while ensuring that it does not impose ineffective and unnecessarily 
burdensome regulations on the public. The rulemaking process should be 
responsive, efficient, cost-effective, and both fair and perceived as 
fair. This is being done in the Department while it must react to the 
contradictory pressures of providing more services with fewer 
resources. The Department of Defense, as a matter of overall priority 
for its regulatory program, adheres to the general principles set forth 
in Executive Order 12866 as amplified below.
Problem Identification
 Congress typically passes legislation to authorize or require an 
agency to issue regulations and often is quite specific about the 
problem identified for correction. Therefore, DoD does not generally 
initiate regulations as a part of its mission.
Conflicting Regulations
 Since DoD seldom issues significant regulations, the probability of 
developing conflicting regulations is low. Conversely, DoD is affected 
to a great degree by the regulating agencies. From that perspective, 
DoD is in a position to advise the regulatory agencies of conflicts 
that appear to exist using the coordination processes that exist in the 
DoD and other Federal agency regulatory programs. It is a priority in 
the Department to communicate with other agencies and the affected 
public to identify and proactively pursue regulatory problems that 
occur as a result of conflicting regulations both within and outside 
the Department.
Alternatives
 DoD will identify feasible alternatives that will obtain the desired 
regulatory objectives. Where possible, the Department encourages the 
use of incentives to include financial, quality of life, and others to 
achieve the desired regulatory results.
Risk Assessment
 Assessing and managing risk is a high priority in the DoD regulatory 
program. The Department is committed to risk prioritization and an 
``anticipatory'' approach to regulatory planning, which focuses 
attention on the identification of future risk. Predicting future 
regulatory risk is exceedingly difficult due to rapid introduction of 
new technologies, side effects of Government intervention, and changing 
societal concerns. These difficulties can be mitigated to a manageable 
degree through the incorporation of risk prioritization and 
anticipatory regulatory planning into DoD's decisionmaking process, 
which results in an improved regulatory process and increases the 
customer's understanding of risk.
Cost-Effectiveness
 One of the highest priority objectives of DoD is to obtain the desired 
regulatory objective by the most cost-effective method available. This 
may or may not be through the regulatory process. When a regulation is 
required, DoD considers incentives for innovation to achieve desired 
results, consistency in the application of the regulation, 
predictability of the activity outcome (achieving the expected 
results), and the costs for regulation development, enforcement, and 
compliance. These will include costs to the public, Government, and 
regulated entities, using the best available data or parametric 
analysis methods, in the cost-benefit analysis and the decisionmaking 
process.

[[Page 72705]]

Cost-Benefit
 Conducting cost-benefit analyses on regulation alternatives is a 
priority in the Department of Defense so as to ensure that the 
potential benefits to society outweigh the costs. Evaluations of these 
alternatives are done quantitatively or qualitatively or both, 
depending on the nature of the problem being solved and the type of 
information and data available on the subject. DoD is committed to 
considering the most important alternative approaches to the problem 
being solved and providing the reasoning for selecting the proposed 
regulatory change over the other alternatives.
Information-Based Decisions
 The Defense Department uses the latest technology to provide access to 
the most current technical, scientific, and demographic information in 
a timely manner through the worldwide communications capabilities that 
are available on the Internet. Realizing that increased public 
participation in the rulemaking process improves the quality and 
acceptability of regulations, DoD is committed to exploring the use of 
information technology (IT) in rule development and implementation. IT 
provides the public with easier and more meaningful access to the 
processing of regulations. Furthermore, the Department endeavors to 
increase the use of automation in the Notice and Comment rulemaking 
process in an effort to reduce time pressures and increase public 
access in the regulatory process. Notable progress has been made in the 
Defense acquisition regulations area toward achieving the 
Administration's E-government initiative of making it simpler for 
citizens to receive high-quality service from the Federal Government, 
inform citizens, and allow access to the development of rules.
Performance-Based Regulations
 Where appropriate, DoD is incorporating performance-based standards 
that allow the regulated parties to achieve the regulatory objective in 
the most cost-effective manner.
Outreach Initiatives
 DoD endeavors to obtain the views of appropriate State, local, and 
tribal officials and the public in implementing measures to enhance 
public awareness and participation both in developing and implementing 
regulatory efforts. Historically, this has included such activities as 
receiving comments from the public, holding hearings, and conducting 
focus groups. This reaching out to organizations and individuals that 
are affected by or involved in a particular regulatory action remains a 
significant regulatory priority of the Department and, we feel, results 
in much better regulations.
 The Department is actively engaged in addressing the requirements of 
the Government Paperwork Elimination Act (GPEA) in implementing 
electronic government and in achieving IT accessibility for individuals 
with disabilities. This is consistent with the Administration's 
strategy of advancing E-government as expressed in ``The President's 
Management Agenda.'' The Department is actively participating in the 
eRulemaking Initiative to develop a Governmentwide docket management 
system that will provide the framework for wider citizen input and 
improve regulatory policies and outcomes by cultivating public 
participation in Federal decisionmaking.
Coordination
 DoD has enthusiastically embraced the coordination process between and 
among other Federal agencies in the development of new and revised 
regulations. Annually, DoD receives regulatory plans from key 
regulatory agencies and has established a systematic approach to 
providing the plans to the appropriate policy officials within the 
Department. Feedback from the DoD components indicates that this 
communication among the Federal agencies is a major step forward in 
improving regulations and the regulatory process, as well as in 
improving Government operations.
Minimize Burden
 In the regulatory process, there are more complaints concerning burden 
than anything else. In DoD, much of the burden is in the acquisition 
area. Over the years, acquisition regulations have grown and become 
burdensome principally because of legislative action. But, in 
coordination with Congress, the Office of Federal Procurement Policy, 
and the public, DoD is initiating significant reforms in acquisition so 
as to effect major reductions in the regulatory burden on personnel in 
Government and the private sector. DoD has implemented a multi-year 
strategy for reducing the paperwork burden imposed on the public. This 
plan shows that DoD has met and will exceed the goals set forth in the 
Paperwork Reduction Act. It is the goal of the Department of Defense to 
impose upon the public the smallest burden viable, as infrequently as 
possible, and for no longer than absolutely necessary.
Plain Language
 Ensuring that regulations are simple and easy to understand is a high 
regulatory priority in the Department of Defense. All too often, the 
regulations are complicated, difficult to understand, and subject to 
misinterpretation, all of which can result in the costly process of 
litigation. The objective in the development of regulations is to write 
them in clear, concise language that is simple and easy to understand.
 DoD recognizes that it has a responsibility for drafting clearly 
written rules that are reader-oriented and easily understood. Rules 
will be written for the customer using natural expressions and simple 
words. Stilted jargon and complex construction will be avoided. Clearly 
written rules will tell our customers what to do and how to do it. DoD 
is committed to a more customer-oriented approach and uses plain 
language rules thereby improving compliance and reducing litigation.
 In summary, the rulemaking process in DoD should produce a rule that: 
Addresses an identifiable problem, implements the law, incorporates the 
President's policies defined in Executive Order 12866, is in the public 
interest, is consistent with other rules and policies, is based on the 
best information available, is rationally justified, is cost-effective, 
can actually be implemented, is acceptable and enforceable, is easily 
understood, and stays in effect only as long as is necessary. Moreover, 
the proposed rule or the elimination of a rule should simply make 
sense.
Regulations Related to the Events of September 11, 2001
 Defense Federal Acquisition Regulation Supplement (DFARS) Case 2003-
D107, Firefighting Service Contracts, implements section 331 of the 
National Defense Authorization Act for Fiscal Year 2004. Section 331 
provides authority for contractor performance of firefighting functions 
at military installations or facilities for periods of one year or 
less, if the functions would otherwise have to be performed by members 
of the Armed Forces who are not readily available by reason of a 
deployment. The interim rule was published in the Federal Register on 
June 25, 2004 (69 FR 35532).
 Federal Acquisition Regulation (FAR) Case 2003-022, Special Emergency 
Procurement Authority, implements section 1443 of the Fiscal Year 2004

[[Page 72706]]

Consolidated Appropriations Act. Section 1443 provides continuing 
authorities for acquisitions of property and services by or for an 
executive agency that are to be used in support of a contingency 
operation or to facilitate defense against or recovery from terrorism 
or nuclear, biological, chemical, or radiological attack. The interim 
rule was published in the Federal Registeron February 23, 2004 (69 FR 
8312).
Suggestions From the Public for Reform--Status of DoD Items
 The Army Corps of Engineers has not undertaken any rulemaking actions 
in response to the public nominations submitted to the Office of 
Management and Budget in 2001 or 2002. Those nominations were discussed 
in ``Making Sense of Regulation: 2001 Report to Congress on the Costs 
and Benefits of Regulations and Unfunded Mandates on State, Local, and 
Tribal Entities'' and ``Stimulating Smarter Regulation: 2002 Report to 
Congress on the Costs and Benefits of Regulations and Unfunded Mandates 
on State, Local, and Tribal Entities.''
 When the Army Corps of Engineers reissued the nationwide permits on 
January 15, 2002 (67 FR 2020), several changes were made to clarify and 
simplify the nationwide permit program. These changes increased 
flexibility in decisionmaking, while enhancing protection of the 
aquatic environment.
 The changes to the regulatory definitions of ``fill material'' and 
``discharge of fill material'' that were published in the May 9, 2002, 
Federal Register resulted from the public notice and comment process 
required by the Administrative Procedures Act. The revised definitions 
provide consistency between Army Corps of Engineers and U.S. 
Environmental Protection Agency (EPA) regulations governing discharges 
of fill material into waters of the United States and do not warrant 
the preparation of an Environmental Impact Statement.
 In the January 15, 2003, issue of the Federal Register (68 FR 1991), 
the Army Corps of Engineers and EPA issued an Advance Notice of 
Proposed Rulemaking (ANPRM) to obtain early comment on issues related 
to the scope of waters subject to Clean Water Act jurisdiction in light 
of the Solid Waste Agency of Northern Cook County v. Army Corps of 
Engineers decision by the U.S. Supreme Court (531 U.S. 159 (2001)). In 
Appendix A of this ANPRM, there is a joint memorandum issued by the 
Corps and EPA that provides clarifying guidance regarding the U.S. 
Supreme Court's decision in this case. This joint memorandum supercedes 
the January 19, 2001, guidance document and addresses several legal 
issues concerning Clean Water Act jurisdiction that have arisen since 
this decision. In response to the ANPRM, approximately 150,000 comments 
were received. On December 16, 2003, the Corps and EPA announced that a 
new rule on Clean Water Act regulatory jurisdiction over isolated 
waters would not be issued.
 The Army Corps of Engineers is continuing its efforts to update and 
clarify the 1987 ``Corps of Engineers Wetlands Delineation Manual'' 
(1987 Manual). This effort may also include the development of regional 
wetland delineation manuals. Any proposed changes to the 1987 Manual, 
or the issuance of regional wetland delineation manuals, will be 
subject to the public notice and comment procedures required by the 
Administrative Procedures Act.
Specific Priorities
 For this regulatory plan, there are four specific DoD priorities, all 
of which reflect the established regulatory principles. In those areas 
where rulemaking or participation in the regulatory process is 
required, DoD has studied and developed policy and regulations that 
incorporate the provisions of the President's priorities and objectives 
under the Executive order.
 DoD has focused its regulatory resources on the most serious 
environmental, health, and safety risks. Perhaps most significant is 
that each of the priorities described below promulgates regulations to 
offset the resource impacts of Federal decisions on the public or to 
improve the quality of public life, such as those regulations 
concerning civil functions of the U.S. Army Corps of Engineers, 
acquisition, installations and the environment, and the Defense 
personnel system.
U.S. Army Corps of Engineers, Directorate of Civil Works
Compensatory Mitigation in the Army Regulatory Program
 Section 314 of the National Defense Authorization Act for Fiscal Year 
2004 (Pub. L. 108-136) requires the Secretary of the Army, acting 
through the Chief of Engineers, to issue regulations that establish 
performance standards and criteria for the use of compensatory 
mitigation for wetland functions lost as a result of activities 
authorized by Department of the Army (DA) permits. The statute also 
requires the regulation to contain provisions for the application of 
equivalent standards and criteria to each type of compensatory 
mitigation. The statutory deadline for publishing the final regulation 
is November 24, 2005.
 The proposed regulation will be developed by considering concepts in 
current Federal compensatory mitigation guidance documents and updating 
and modifying those concepts to improve compensatory mitigation 
decisionmaking and processes. We believe that the proposed regulation 
should take a watershed approach to compensatory mitigation for 
permitted impacts to wetlands, streams, and other aquatic resources. 
Although the statute refers only to wetlands, we believe that the 
regulation should be broader in scope and address compensatory 
mitigation requirements for impacts to other aquatic resources, such as 
streams, in addition to wetlands.
Army Regulatory Program's Compliance With the National Historic 
Preservation Act
 In 1990, the Army Corps of Engineers published as appendix Cof 33 CFR 
part 325, a rule that governs compliance with the National Historic 
Preservation Act (NHPA) for the Army's Regulatory Program. Over the 
years, there have been substantial changes in policy, and the NHPA was 
amended in 1992, leading to the publication in December 2000 of new 
implementing regulations at 36 CFR part 800, issued by the Advisory 
Council on Historic Preservation. Those regulations were amended on 
July 6, 2004. The Advisory Council on Historic Preservation's 
regulations allow Federal agencies to utilize alternate procedures in 
lieu of the regulations at 36 CFR part 800. To solicit public comment 
on the appropriate mechanism for revising the Army Regulatory Program's 
process for considering effects to historic properties resulting from 
activities authorized by DA permits, the Army Corps of Engineers 
published an Advance Notice of Proposed Rulemaking to obtain the views 
of interested parties. After reviewing the comments received in 
response to the ANPRM, the Army Corps of Engineers may develop and 
propose, in fiscal year 2005, agency alternate procedures to comply 
with the requirements of section 106 of the National Historic 
Preservation Act.
Defense Procurement and Acquisition
 The Department continues its efforts to reengineer its acquisition 
system to

[[Page 72707]]

achieve its vision of an acquisition system that is recognized as being 
the smartest, most efficient, most responsive buyer of best value goods 
and services, which meet the warfighter's needs from a globally 
competitive base. To achieve this vision, the Department will focus in 
the acquisition regulations during this next year on implementing and 
institutionalizing initiatives that may include additional changes to 
existing and recently modified regulations to ensure that we are 
achieving the outcomes we desire (continuous process improvement).
 The Department of Defense continuously reviews its supplement to the 
Federal Acquisition Regulation (FAR) and continues to lead Government 
efforts to simplify the following acquisition processes:
 Transform the Defense Federal Acquisition Regulation 
            Supplement(DFARS) to improve the efficiency and 
            effectiveness of the acquisition process, while allowing 
            the acquisition workforce flexibility to innovate. The 
            transformed DFARS will contain only requirements of law, 
            DoD-wide policies, delegations of FAR authorities, 
            deviations from FAR requirements, and policies/procedures 
            that have a significant effect beyond the internal 
            operating procedures of DoD or a significant cost or 
            administrative impact on contractors or offerors.
 Provide uniform treatment of contractor personnel whoprovide 
            support in theater to a force deployed outside the United 
            States in contingency operations, humanitarian or 
            peacekeeping operations, and other major military 
            operations or training exercises designated by the 
            Combatant Commander.
 Implement new Free Trade Agreements and revise the FARand 
            DFARS subparts on trade agreements, to make terminology 
            consistent with our international agreements.
 Finalize the rewrite of FAR part 27, Patents, Data 
            andCopyrights, to clarify, streamline, and update guidance 
            and clauses on patents, data, and copyrights.
 Provide guidance on acceptability of photocopies of powersof 
            attorney for bid bonds and allow treatment of questions 
            regarding the authenticity and enforceability of the power 
            of attorney at the time of bid opening as a matter of 
            responsibility.
 Review various FAR cost principles to determine whethercertain 
            FAR cost principles are still relevant in today's business 
            environment, whether they place an unnecessary 
            administrative burden on contractors and the Government, 
            and whether they can be streamlined or simplified.
 Revise policy on the applicability of cost 
            accountingstandards. The goal of this initiative is to 
            modify and streamline the applicability of Federal cost 
            accounting standards.
 Phase in requirements for contractors to affix radio 
            frequencyidentification (RFID) tags to items delivered 
            under DoD contracts. This practice will improve visibility 
            of DoD assets in the supply chain, increase the accuracy of 
            shipment and receipt data, and reduce the amount of time it 
            takes to deliver material to the warfighter.
 Consider FAR and DFARS changes to facilitate timely 
            contractcloseout.
 Implement Earned Value Management in the FAR.
 Revise the FAR part 45, Government Property, to organizeand 
            streamline the management of Government property.
Defense Installations and the Environment
 The Department is committed to reducing the total ownership costs of 
the military infrastructure while providing the Nation with military 
installations that efficiently support the warfighter in: Achieving 
military dominance, ensuring superior living and working conditions, 
and enhancing the safety of the force and the quality of the 
environment. DoD has focused its regulatory priorities on explosives 
safety, human health, and the environment. These regulations provide 
means for the Department to provide information about restoration 
activities at Federal facilities and to take public advice on the 
restoration activities.
Restoration Advisory Boards
 The requirement for the establishment of Restoration Advisory Boards 
(RABs) is grounded in section 324(a) of Public Law 104-106, which 
requires the Secretary of Defense to ``prescribe regulations regarding 
the establishment, characteristics, composition, and funding of 
restoration advisory boards.'' Section 324(a) also stated that DoD's 
issuance of regulations shall not be a precondition to the 
establishment of RABs (amended section 2705(d)(2)(B)). In August 1996, 
the Department proposed and requested public comments on regulations 
regarding the characteristics, composition, funding, and establishment 
of RABs. These regulations were not finalized.
 As a consequence of litigation in 2001, the Department substantially 
revised the regulations and shared a draft of the RAB Rule with RAB 
community members as part of the Department's outreach to affected 
members of the public. On March 26, 2003, OMB reviewed the Draft 
Proposed RAB Rule and agreed that it is not a ``significant regulatory 
action'' under Executive Order 12866. DoD has incorporated all 
appropriate community members' comments and provided a revised Draft 
Proposed RAB Rule to OMB for interagency review prior to publication in 
the Federal Register.
 Because the applicability of the Federal Advisory Committee Act (FACA) 
to RABs was unclear, DoD sought a statutory clarification. Section 317 
of the fiscal year 2004 National Defense Authorization Act provides 
that FACA does not apply to RABs. The revised Draft Proposed RAB Rule 
reflects this clarification.
Munitions Response Site Prioritization Protocol
 Section 2710(b)(1) of title 10, United States Code, directs the 
Secretary of Defense to develop, in consultation with representatives 
of the States and Indian tribes, a proposed protocol for assigning to 
each defense site a relative priority for munitions response 
activities. Section 2710 provides for public notice and comment on the 
proposed protocol and requires that the proposed protocol be available 
for public comment on or before November 30, 2002. DoD is directed to 
issue a final protocol to be applied to defense sites listed in the 
Department's munitions response site inventory.
 The Department met with State and tribal representatives and also 
representatives of other Federal agencies during preparation of the 
proposed rule published on August 22, 2003. The Department reviewed and 
incorporated comments from the 16 sets of comments received during the 
public comment period, which ended on November 19, 2003. The draft 
final rule is under review within the Department, which plans to 
publish the final rule in fiscal year 2005.
 Most of the changes pertain to clarification of terms and definitions 
based on comments received or new statutory definitions promulgated in 
the National Defense Authorization Act for Fiscal Year 2004 and 
codified at 10 U.S.C. section 101. The most significant change to the 
proposed rule pertains to

[[Page 72708]]

the module that evaluates health hazards associated with munitions 
constituents and other chemical constituents. The Department also 
revised the rule to clarify that current landowners may participate in 
the application of the rule at Formerly Used Defense Sites and that the 
quality assurance panel that reviews each priority score will consist 
only of Department personnel.
National Security Personnel System
 The National Defense Authorization Act for Fiscal Year 2004 (Pub. L. 
108-136, November 24, 2003) provided the Department of Defense (DoD) 
the authority to establish a more flexible civilian personnel 
management system. The National Security Personnel System (NSPS) will 
allow the Department to be a more competitive and progressive employer 
at a time when the country's national security demands a highly 
responsive system of civilian personnel management.
 NSPS will establish new rules for how DoD civilians are hired, 
assigned, compensated, promoted, and disciplined. NSPS will also 
address the Department's labor relations and appeals processes. This 
will all be within the framework of merit principles, veterans' 
preference, and employees' rights to organize and bargain collectively. 
The goal of NSPS is to strengthen DoD's ability to accomplish its 
mission in an ever-changing defense environment.
 In April 2004, the Department established a DoD Program Executive 
Office, National Security Personnel System (PEO-NSPS) to manage, 
oversee, and coordinate the development, design, and implementation of 
NSPS throughout the Department. This includes drafting (with OPM) 
regulations establishing NSPS.
Human Resources Management System
 Section 9902(a) of Public Law 108-136 authorizes the Secretary of 
Defense and the Director of the Office of Personnel Management (OPM) to 
issue jointly prescribed regulations to establish a human resources 
management system for the Department of Defense. These regulations will 
provide for new rules and flexibilities in the areas of:
 Position classification and pay
 Performance management (including a pay for performancesystem, 
            as required in section 9902(b)(6)(I) of Public Law 108-136)
 Hiring, assignment, and reduction in force
Labor Management Relations System
 Section 9902(m) of Public Law 108-136 authorizes the Secretary of 
Defense and the Director, OPM, to establish a new labor management 
relations system for the Department and to allow for a collaborative, 
issue-based approach to labor management relations. Regulations 
developed jointly with OPM will provide a new framework for labor 
relations in DoD, with the goal of streamlined processes to allow for 
quicker and more efficient resolution of labor relations issues, while 
preserving collective bargaining rights for DoD employees.
Employee Appeals
 Section 9902(h) of Public Law 108-136 provide the Secretary of Defense 
with authority to establish an appeals process in conjunction with NSPS 
to provide employees fair treatment in decisions relating to their 
employment. The new appeals will be designed to streamline appeals 
procedures while ensuring that employees are afforded the protections 
of due process, as required by law.
NSPS Design Process and Timeline
 The design of NSPS (which will result in regulations to be issued in 
the Federal Register) includes an extensive outreach effort to gather 
input and feedback from a variety of stakeholder groups, including DoD 
labor unions, employees, supervisors, managers, military commanders, 
and external groups such as veteran service organizations, (non-union) 
employee interest groups, and ``good-government'' groups. DoD working 
groups, comprised of DoD and OPM human resources experts, line 
managers, and system practitioners (e.g., legal, EEO) met in the late 
summer 2004 to identify and craft NSPS design options. In addition, DoD 
and OPM have met several times with DoD labor union representatives to 
gather input and discuss potential system designs.
Once NSPS design options are decided upon by DoD and OPM senior 
leadership, proposed regulations establishing and governing NSPS will 
be published via the Federal Register for public comment. The 
Department plans to issue proposed NSPS regulations in December 2004, 
Statutory procedures for collaborating with employee representatives on 
the content of the regulations are provided in sections 9902(f) and 
9902(m)(3).
BILLING CODE 5001-06-S

[[Page 72709]]


DEPARTMENT OF EDUCATION (ED)



Statement of Regulatory and Deregulatory Priorities
General
 We support States, local communities, institutions of higher 
education, and others to improve education nationwide. Our roles 
include providing leadership and financial assistance for education to 
agencies, institutions, and individuals in situations in which there is 
a national interest; monitoring and enforcing Federal civil rights laws 
in programs and activities that receive Federal financial assistance; 
and supporting research, evaluation, and dissemination of findings to 
improve the quality of education.
 The 4,300 employees of our Department help to realize the educational 
promise of America. We administer programs, grants, and loans that 
touch nearly every American at one point in their lives--approximately 
14,000 public school districts, nearly 54 million students attending 
93,000 elementary and secondary schools, and almost 22 million 
postsecondary students.
 To connect our customers to a ``one-stop-shopping'' center for 
information about our programs and initiatives, we instituted 1-800-
USA-LEARN (1-800-872-5327). We also set up 1-800-4FED-AID (1-800-433-
3243) for information on student aid, and we provide an online library 
of information on education legislation, research, statistics, and 
promising programs at the following Internet address: http://www.ed.gov
 More than 763,225 people take advantage of these resources every week. 
In addition, our Office of Internal Communications established for the 
summer a Visitors Center at our headquarters. From Memorial Day to 
Labor Day, the center was staffed by employee volunteers who were 
trained to engage the public and respond to their inquiries. Some 1,000 
visitors stopped by to give their views on education, learn about the 
No Child Left Behind Act and other Federal education legislation, and 
find out about resources and materials that we offer. We gave young 
children a special ``Visitors Center Activity Book,'' and talked with 
adults about our online resources.
 We have forged effective partnerships with customers and others to 
develop policies, regulations, guidance, technical assistance, and 
approaches to compliance. We have a record of successful communication 
and shared policy development with affected persons and groups, 
including parents, students, educators, representatives of State, 
local, and tribal governments, neighborhood groups, schools, colleges, 
special education and rehabilitation service providers, professional 
associations, advocacy organizations, businesses, and labor 
organizations.
 In particular, we continue to seek greater and more useful customer 
participation in our rulemaking activities through the use of 
consensual rulemaking and new technology. If we determine that the 
development of regulations is absolutely necessary, we seek customer 
participation at all stages--in advance of formal rulemaking, during 
rulemaking, and after rulemaking is completed in anticipation of 
further improvements through statutory or regulatory changes. We have 
expanded our outreach efforts through the use of satellite broadcasts, 
electronic bulletin boards, and teleconferencing. For example, we 
invite comments on all proposed regulations through the Internet.
 We are continuing our efforts to streamline information collections, 
reduce burden on information providers involved in our programs, and 
make information maintained by us easily available to the public. To 
the extent permitted by statute, we will revise regulations to 
eliminate barriers that inhibit coordination across programs (such as 
by creating common definitions). This should help reduce the frequency 
of reports and eliminate unnecessary data requirements.
We currently have in place four Internet-based software applications: 
e-Application, e-Reports, e-Reader, and e-Administration. These enable 
applicants, grantees, and grant teams to file, review, and process 
applications and performance reports and to make administrative changes 
online. These applications were implemented in pilot phases between FY 
2000 and 2003, and the program participation in these initiatives 
continues to grow each year. In addition, we are participating in the 
Governmentwide Grants.gov Find and Apply portal, which is a one-stop 
shopping site allowing grant applicants to find and apply for funding 
opportunities from agencies across the Federal government.
New Initiatives
 We have recently implemented an Enterprise-Wide Risk Management 
initiative. The goal of this initiative is to mitigate concentrations 
of risk (including the risk of improper or erroneous payments) within 
our portfolio of grants, loans, and other operations by focusing human, 
financial, and technical resources to achieve targeted results. We have 
begun to identify a number of entities that have concentrations of risk 
(e.g., incomplete audits, qualified audit reports, and more that $1 
million of funds at risk of reverting to Treasury), and we will be 
taking positive steps to partner with these entities to mitigate the 
risks.
 We are also focusing on strategic management of human capital. Efforts 
are being taken to reduce the number of vacancies and the time it takes 
to fill those vacancies, clarify expectations of results, and enhance 
the performance appraisal process to promote differentiating among 
performance levels and to provide clear and effective feedback. We are 
also focused on strengthening and developing leadership talent by 
analyzing the critical skill needs of the organization, providing 
training based on identified leadership competencies, and implementing 
an executive leadership development program that will contribute to the 
depth and breadth of leaders at the Department.
 Among our other new undertakings, the Secretary announced the Teacher-
to-Teacher Initiative through which some of the Nation's best teachers 
and educational experts will have the opportunity to share with their 
colleagues classroom practices that have been successful in raising 
student performance and closing the achievement gap. The initiative 
includes ongoing workshops for teachers, teacher and principal 
roundtables, a national teacher summit, a ``Toolkit for Teachers'' 
containing resource materials, a weekly e-mail update entitled 
``Teacher E-Bytes,'' and ``American Stars of Teaching,'' which focuses 
attention on effective teachers who are making a real difference in 
their students' lives.
No Child Left Behind
 The No Child Left Behind Act of 2001, which reauthorized the 
Elementary and Secondary Education Act of 1965, increases 
accountability for States, school districts, and schools; provides 
greater choice for parents and students, particularly those attending 
low-performing schools; provides more flexibility for States and local 
educational agencies in the use of Federal education dollars; and 
places a stronger emphasis on reading, especially for our youngest 
children.

[[Page 72710]]

 Each State, Puerto Rico, and the District of Columbia has submitted an 
accountability plan, which the Department approved. Each submitting 
jurisdiction has used its respective plan to hold schools and school 
districts accountable in school years 2002-03 and 2003-04 for all their 
students, including students in specific subgroups such as students 
with disabilities and limited English proficient (LEP) students.
 With respect to students with disabilities and LEP students, in 
particular, the Department recently initiated regulatory actions to 
address unique issues. We issued final regulations that permit a State 
to (1) develop alternate achievement standards for students with the 
most significant cognitive disabilities and (2) include those students' 
proficient and advanced scores in adequate yearly progress (AYP) 
determinations, subject to a cap of one percent. We also published 
proposed regulations to permit a State to (1) exempt LEP students new 
to schools in the United States from one administration of the State's 
reading assessment and (2) include, for up to 2 years, former LEP 
students in the LEP subgroup for making AYP determinations.
 We shall continue to focus on helping States place a highly qualified 
teacher in every classroom; identifying schools and districts in need 
of improvement and making sure they are getting the assistance they 
need to get back on track; expanding the opportunities for eligible 
students to receive tutoring and other supplemental services; and 
helping districts create capacity in order to make public school choice 
available to all eligible students who wish to transfer schools.
We shall also begin to peer review the new State content and student 
achievement standards and aligned assessment systems required by the No 
Child Left Behind Act. These must be in place by the 2005-06 school 
year.
Principles for Regulating
 Our Principles for Regulating determine when and how we will regulate. 
Through consistent application of the following principles, we have 
eliminated unnecessary regulations and identified situations in which 
major programs could be implemented without any regulations or with 
only limited regulations.
 We will regulate only if regulating improves the quality and equality 
of services to our customers, learners of all ages. We will regulate 
only if absolutely necessary and then in the most flexible, most 
equitable, and least burdensome way possible.
 Whether to regulate:
 When essential to promote quality and equality of opportunity 
            in education.
 When a demonstrated problem cannot be resolved without 
            regulation.
 When necessary to provide legally binding interpretation to 
            resolve ambiguity.
 Not if entities or situations to be regulated are so diverse 
            that a uniform approach does more harm than good.
 How to regulate:
 Regulate no more than necessary.
 Minimize burden and promote multiple approaches to meeting 
            statutory requirements.
 Encourage federally funded activities to be integrated with 
            State and local reform activities.
 Ensure that benefits justify costs of regulation.
 Establish performance objectives rather than specify 
            compliance behavior.
 Encourage flexibility so institutional forces and incentives 
            achieve desired results.
Regulatory and Deregulatory Priorities for the Next Year
 Reauthorization of the Individuals With Disabilities Education Act 
(IDEA), parts C and D, and anticipated amendments to parts A and B, 
will make changes considered to be necessary to improve the 
implementation of the education of children with disabilities program 
(including pre-school services) and the early intervention program for 
infants and toddlers with disabilities under parts B and C and the 
effectiveness of national discretionary grants, contracts, and 
cooperative agreements in improving the education of children with 
disabilities under part D. The Secretary solicited public comment on 
the reauthorization of IDEA using the underlying framework of the 
President's principles of education reform to ensure that no child is 
left behind.
Reauthorization of the Higher Education Act of 1965 (HEA) will make 
changes considered necessary to the grant, loan, and work assistance 
programs authorized under title IV of the HEA in order to improve 
educational quality, expand access, and ensure affordability in 
postsecondary education. This reauthorization will seek to balance the 
reduction of burdensome requirements, especially on students, with the 
need to adequately safeguard taxpayers' funds. It would also make 
changes considered necessary to improve the implementation of the 
teacher quality enhancement programs under title II of the HEA, the 
institutional assistance programs under titles III and V of the HEA, 
the international and foreign language studies programs under title VI 
of the HEA, and the graduate education and postsecondary education 
improvement programs under title VII of the HEA.
_______________________________________________________________________

ED--Office of Special Education and Rehabilitative Services (OSERS)

                              -----------

                             PRERULE STAGE

                              -----------




35. REAUTHORIZATION OF THE INDIVIDUALS WITH DISABILITIES EDUCATION ACT 
(SECTION 610 REVIEW)
Priority:


Other Significant. Major status under 5 USC 801 is undetermined.


Unfunded Mandates:


Undetermined


Legal Authority:


20 USC 1400 to 1487


CFR Citation:


34 CFR ch III


Legal Deadline:


None


Abstract:


These regulations would implement changes made by the anticipated 
reauthorization of the Individuals With Disabilities Education Act. 
This action is a notice that, if regulations are necessary, ED would 
review the regulations in 34 CFR chapter III under section 610 of the 
Regulatory Flexibility Act (5 U.S.C. 610). The purpose of this review 
would be to determine if these regulations should be continued without 
change, or should be amended or rescinded, to minimize any significant 
economic impact upon a substantial number of small entities. We would 
request comments on the continued need for the regulations; the 
complexity of the regulations; the extent to which they overlap, 
duplicate, or conflict with other Federal, State, or local government 
regulations; and the degree to which technology, economic

[[Page 72711]]

conditions, or other relevant factors have changed since the 
regulations were promulgated.


Statement of Need:


These regulations may be necessary to implement new legislation. ED 
would also complete its review of these regulations under section 
610(c) of the Regulatory Flexibility Act. In developing any 
regulations, the Department would seek to reduce regulatory burden and 
increase flexibility to the maximum extent possible.


Summary of Legal Basis:


New legislation.


Alternatives:


In addition to implementing the anticipated reauthorization of the 
Individuals With Disabilities Education Act, the purpose of this review 
would be to determine whether there are appropriate alternatives.


Anticipated Cost and Benefits:


Existing regulatory provisions may be eliminated or improved as a 
result of this review.


Risks:


These regulations would not address a risk to public health, safety, or 
the environment.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Notice          67 FR 1411                                     01/10/02
ANPRM                                                          02/00/05
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


URL For Public Comments:
www.regulations.gov
Agency Contact:
JoLeta Reynolds
Department of Education
Office of Special Education and Rehabilitative Services
Room 3082
Room 4150, PCP
400 Maryland Avenue SW
Washington, DC 20202-2570
Phone: 202 245-7494
RIN: 1820-AB54
BILLING CODE 4000-01-S

[[Page 72712]]


DEPARTMENT OF ENERGY (DOE)



Statement of Regulatory and Deregulatory Priorities
 The Department makes vital contributions to the Nation's welfare 
through its extraordinary scientific and technical capabilities in 
energy research, environmental remediation, and national security. The 
Department's mission is to:
 Foster a secure and reliable energy system that is 
            environmentallyand economically sustainable;
 Provide responsible stewardship of the Nation'snuclear 
            weapons;
 Clean up the Department'sfacilities;
 Lead in the physical sciences and advance the 
            biological,environmental and computational sciences; and,
 Provide premiere instruments of science for the 
            Nation'sresearch enterprise.
 The Department of Energy's regulatory plan reflects the Department's 
continuing commitment to enhance safety, cut costs, reduce regulatory 
burden, and increase responsiveness to the public. While not primarily 
a major Federal regulatory agency, the Department's regulatory 
activities are essential to achieving its critical mission and to 
implementing major initiatives in the President's National Energy Plan.
Energy Efficiency Program for Consumer Products and Commercial 
Equipment
 The Department's priorities for its rulemaking activities related to 
energy efficiency standards and determinations, which have been 
established with significant input from the public, are reflected in 
the rulemaking schedules set forth in The Regulatory Plan and the 
Unified Agenda of Federal Regulatory and Deregulatory Actions.
 During the coming year, the Department expects to revise the energy 
efficiency standards for residential furnaces and boilers; electric 
distribution transformers; and for commercial unitary air conditioners 
and heat pumps. Additional information and timetables for these actions 
can be found below. In addition, the Department will continue working 
on the analyses required to revise the standards for packaged terminal 
air conditioners and heat pumps, oil- and gas-fired commercial packaged 
boilers, tankless gas-fired instantaneous water heaters, 3-phased air 
conditioners and heat pumps, and single package vertical air 
conditioners and heat pumps.
 The Department plans to publish final rules concerning test procedures 
for residential central air conditioners and heat pumps and electric 
distribution transformers. Information and timetables concerning these 
actions can be found in the Department's regulatory agenda, which 
appears elsewhere in this issue of the Federal Register.
Nuclear Safety Regulations
The Department is committed to openness and public participation as it 
addresses one of its greatest challenges--managing the environment, 
health, and safety risks posed by its nuclear activities. A key element 
in the management of these risks is to establish the Department's 
expectations and requirements relative to nuclear safety and to hold 
its contractors accountable for safety performance. The 1988 Price-
Anderson Amendments Act revisions to the Atomic Energy Act of 1954 
(AEA) provide for the imposition of civil and criminal penalties for 
violations of DOE nuclear safety requirements. As a result, new nuclear 
safety requirements were initiated with the publication of four notices 
of proposed rulemaking for review and comment in 1991. The Department's 
nuclear safety procedural regulations (10 CFR part 820) were published 
as a final rule in 1993. The Department's substantive nuclear safety 
requirements (10 CFR parts 830 and 835) were finalized in 2001 and 
1998, respectively. The remaining action, 10 CFR part 834, Radiation 
Protection and the Environment, is scheduled for publication by the end 
of 2006. In addition, the Department will be proposing in November 2004 
to add a new part, 10 CFR 851, Worker Safety and Health, that would 
establish basic requirements to ensure workers are protected from 
safety and health hazards at DOE facilities.
_______________________________________________________________________

DOE--Energy Efficiency and Renewable Energy (EE)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




36. ENERGY EFFICIENCY STANDARDS FOR RESIDENTIAL FURNACES AND BOILERS
Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


This action may affect the private sector under PL 104-4.


Legal Authority:


42 USC 6295


CFR Citation:


10 CFR 430


Legal Deadline:


Final, Statutory, January 1, 1994.


Abstract:


The Energy Policy and Conservation Act (EPCA), as amended, establishes 
initial energy efficiency standard levels for most types of major 
residential appliances and generally requires DOE to undertake two 
subsequent rulemakings, at specified times, to determine whether the 
extant standard for a covered product should be amended.


This is the initial review of the statutory standards for residential 
furnaces and boilers.


Statement of Need:


Experience has shown that the choice of residential appliances and 
commercial equipment being purchased by both builders and building 
owners is generally based on the initial cost rather than on life-cycle 
costs. Thus, the law requires minimum energy efficiency standards for 
appliances to eliminate inefficient appliances and equipment from the 
market.


Summary of Legal Basis:


EPCA establishes initial energy efficiency standard levels for most 
types of major residential appliances and certain commercial equipment. 
EPCA generally requires DOE to undertake rulemakings, at specified 
times, to determine whether the standard for a covered product should 
be made more stringent.


Alternatives:


The statute requires the Department to conduct rulemakings to review 
standards and to revise standards to achieve the maximum improvement in 
energy efficiency that the Secretary determines is technologically 
feasible and economically justified. In making this determination, the 
Department conducts a thorough analysis of the alternative standard 
levels, including the existing standard, based on criteria specified by 
statute. The process improvements that were announced (61 FR 36974, 
July 15, 1996) further enhance the analysis of alternatives in

[[Page 72713]]

the appliance standards development process. For example, under this 
process, the Department will ask stakeholders and private sector 
technical experts to review its analyses of the likely impacts, costs, 
and benefits of alternative standard levels. In addition, the 
Department will solicit and consider information on nonregulatory 
approaches for encouraging the purchase of energy efficient products.


Anticipated Cost and Benefits:


The specific costs and benefits of this rulemaking have not been 
established because the final standard levels have not been determined. 
Nevertheless, existing appliance standards are projected to save 23 
quadrillion Btus of energy from 1993 to 2015, resulting in estimated 
consumer savings of $1.7 billion per year in 2000 and estimated annual 
emission reductions of 107 million tons of carbon dioxide and 280 
thousand tons of nitrogen oxides in that year. Under the existing 
standards, the discounted energy savings for consumers are 2.5 times 
greater than the upfront price premium paid for the appliance.


Risks:


Without appliance standards, energy use will continue to increase with 
resulting damage to the environment caused by atmospheric emissions. 
Enhancing appliance energy efficiency reduces atmospheric emissions 
such as CO2 and NOx. Establishing standards that are too stringent 
could result in excessive increases in the cost of the product and 
possible reductions in product utility. It might also place an undue 
burden on manufacturers that could result in loss of jobs or other 
adverse economic impacts.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           58 FR 47326                                    09/08/93
Framework Workshop                                             07/17/01
Venting Workshop                                               05/08/02
ANPRM           69 FR 45419                                    07/29/04
DOE Review of Technical Support Documents                      09/00/05
NPRM                                                           09/00/06
Final Action                                                   09/00/07
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


Local, State


Additional Information:


The timetable for this action reflects program priorities, which were 
established with significant input from the public.


Agency Contact:
Mohammed Kahn, EE-2J
Department of Energy
Energy Efficiency and Renewable Energy
Office of Building Technologies Program
1000 Independence Avenue SW.
Washington, DC 20585
Phone: 202 586-7892
Email: [email protected]
RIN: 1904-AA78
_______________________________________________________________________

DOE--EE



37. ENERGY EFFICIENCY STANDARDS FOR ELECTRIC DISTRIBUTION TRANSFORMERS
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


42 USC 6317


CFR Citation:


10 CFR 430


Legal Deadline:


None


Abstract:


The Energy Policy and Conservation Act, as amended, (EPCA) establishes 
initial energy efficiency standard levels for certain types of major 
residential appliances and certain types of commercial equipment. EPCA 
contains no energy efficiency standards for distribution transformers. 
This rulemaking will determine whether it is appropriate to establish 
such standards.


Statement of Need:


Experience has shown that the choice of residential appliances and 
commercial equipment being purchased by both builders and building 
owners is generally based on the initial cost rather than on life-cycle 
cost. Thus, the law requires minimum energy efficiency standards for 
appliances to eliminate inefficient appliances and equipment from the 
market.


Summary of Legal Basis:


EPCA establishes initial energy efficiency standard levels for certain 
types of major residential appliances and certain types of commercial 
equipment and generally requires DOE to undertake rulemakings, at 
specified times, to establish the standards for those covered products 
without statutory standards.


Alternatives:


The statute requires DOE to conduct rulemakings to review standards and 
to revise standards to achieve the maximum improvement in energy 
efficiency that the Secretary determines is technologically feasible 
and economically justified. In making this determination, the 
Department conducts a thorough analysis of alternative standard levels, 
including the existing standard, based on criteria specified by 
statute. The process improvements that were announced (61 FR 36974, 
July 15, 1996) further enhance the analysis of alternative standards. 
For example, DOE will ask stakeholders and private sector technical 
experts to review its analyses of the likely impacts, costs, and 
benefits of alternative standard levels. In addition, the Department 
will solicit and consider information on nonregulatory approaches for 
encouraging the purchase of energy efficient products.


Anticipated Cost and Benefits:


The specific costs and benefits for this rulemaking have not been 
established because the final standard levels have not been determined. 
Nevertheless, existing appliance standards are projected to save 23 
quadrillion Btus of energy from 1993 to 2015, resulting in estimated 
consumer savings of $1.7 billion per year in the year 2000 and 
estimated annual emission reductions of 107 million tons of carbon 
dioxide and 280 thousand tons of nitrogen oxides in the year 2000. 
Under the existing standards, the discounted energy savings for 
consumers are 2.5 times greater than the up-front price premium paid 
for the appliance.


Risks:


Without appliance efficiency standards, energy use will continue to 
increase with resulting damage to the environment caused by atmospheric 
emissions. Enhancing appliance energy efficiency reduces atmospheric 
emissions of carbon dioxide and nitrogen oxides. Establishing standards 
that are too stringent could result in excessive increases in the cost 
of the product, possible reductions in product utility and may place an 
undue burden on manufacturers that could result in a loss of jobs or 
other adverse economic impacts.

[[Page 72714]]

Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Determination No62 FR 54809                                    10/22/97
ANPRM           69 FR 45375                                    07/29/04
DOE Review of Technical Support Documents                      09/00/05
NPRM                                                           09/00/06
Final Action                                                   09/00/07
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


None


Additional Information:


The timetable for this action reflects program priorities, which were 
established with significant input from the public.


Agency Contact:
Sam Johnson, EE-2J
Department of Energy
Energy Efficiency and Renewable Energy
Office of Building Technologies Program
1000 Independence Avenue SW.
Washington, DC 20585
Phone: 202 586-0854
Fax: 202 586-4617
Email: [email protected]
RIN: 1904-AB08
_______________________________________________________________________

DOE--EE



38. ENERGY EFFICIENCY STANDARDS FOR COMMERCIAL UNITARY AIR CONDITIONERS 
AND HEAT PUMPS
Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


This action may affect the private sector under PL 104-4.


Legal Authority:


42 USC 6293


CFR Citation:


10 CFR 431


Legal Deadline:


None


Abstract:


The Energy Policy and Conservation Act (EPCA), as amended, establishes 
initial energy efficiency standard levels for certain types of major 
residential appliances and certain types of commercial equipment. EPCA 
requires DOE to amend the standards for products whenever ASHRAE amends 
its standards.


Statement of Need:


Experience has shown that the choice of residential appliances and 
commercial equipment being purchased by both builders and building 
owners is generally based on the initial cost rather than on life-cycle 
cost. Thus, the law requires minimum energy efficiency standards for 
appliances to eliminate inefficient appliances and equipment from the 
market.


Summary of Legal Basis:


EPCA establishes initial energy efficiency standard levels for certain 
types of major residential appliances and certain types of commercial 
equipment and requires DOE to amend the standard for this product when 
ASHRAE amends its standards, as recently occurred. DOE can establish a 
more stringent standard than the ASHRAE standard, if DOE determines by 
clear and convincing evidence that such higher standard is 
technologically feasible and economically justified and would result in 
additional energy conservation.


Alternatives:


The statute requires DOE to conduct rulemakings to review standards and 
to revise standards to achieve the maximum improvement in energy 
efficiency that the Secretary determines is technologically feasible 
and economically justified. In making this determination, the 
Department conducts a thorough analysis of alternative standard levels, 
including the existing standard, based on criteria specified by 
statute. The process improvements that were announced (61 FR 36974, 
July 15, 1996) further enhance the analysis of alternative standards. 
For example, DOE will ask stakeholders and private sector technical 
experts to review its analyses of the likely impacts, costs, and 
benefits of alternative standard levels. In addition, the Department 
will solicit and consider information on nonregulatory approaches for 
encouraging the purchase of energy efficient products.


Anticipated Cost and Benefits:


The specific costs and benefits for this rulemaking have not been 
established because the final standard levels have not been determined.


Risks:


Without energy efficiency standards, energy use will continue to 
increase with resulting damage to the environment caused by atmospheric 
emissions. Enhancing energy efficiency reduces atmospheric emissions of 
carbon dioxide and nitrogen oxides. Establishing standards that are too 
stringent could result in excessive increases in the cost of the 
product, possible reductions in product utility and may place an undue 
burden on manufacturers that could result in a loss of jobs or other 
adverse economic impacts.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Screening Worksh66 FR 43123                                    10/01/01
ANPRM           69 FR 45459                                    07/29/04
DOE Review of Technical Support Documents                      09/00/05
NPRM                                                           09/00/06
Final Action                                                   09/00/07
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


None


Additional Information:


The timetable for this action reflects program priorities, which were 
established with significant input from the public.


Agency Contact:
James Raba, EE-2J
Department of Energy
Energy Efficiency and Renewable Energy
Office of Building Technologies Program
1000 Independence Avenue SW.
Washington, DC 20585
Phone: 202 586-8654
Email: [email protected]
RIN: 1904-AB09
_______________________________________________________________________

DOE--Departmental and Others (ENDEP)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




39. WORKER SAFETY AND HEALTH
Priority:


Other Significant


Legal Authority:


42 USC 2011; 42 USC 5801 to 5911; 42 USC 7101 to 7352


CFR Citation:


10 CFR 851

[[Page 72715]]

Legal Deadline:


Final, Statutory, December 2, 2003.


Abstract:


This action would add a new 10 CFR 851 regulation to DOE's regulations 
establishing a body of rules setting forth basic requirements to ensure 
workers are protected from safety and health hazards at DOE facilities.


Statement of Need:


The purpose of this rule is to ensure that the Department's obligation 
to protect the safety and health of its workers is fulfilled and to 
provide, if needed, a basis for the imposition of civil penalties 
consistent with section 3173 of the Bob Stump National Defense 
Authorization Act of 2003. This action is consistent with the 
Department's commitment to the issuance of safety and health 
requirements using notice and comment rulemaking.


Summary of Legal Basis:


Under the Atomic Energy Act of 1954 (AEA), as amended, the Department 
of Energy has the authority to regulate activities at facilities under 
its jurisdiction. On December 2, 2002, section 3173 of the National 
Defense Authorization Act amended the AEA to add section 234C (codified 
as 42 U.S.C. 2282c). Section 234C requires the Department to promulgate 
regulations for industrial and construction safety and health at DOE 
contractor facilities for contractors covered by an agreement of 
indemnification. The regulation must provide a level of protection to 
workers at such facilities that is substantially equivalent to the 
level of protection currently being provided to workers. Section 234C 
also makes DOE contractors that violate the safety and health 
regulations subject to civil penalties or a reduction of fees and other 
payments under its contract with DOE.


Alternatives:


None


Anticipated Cost and Benefits:


The incremental costs of the proposed rules should be minimal because 
contractors are currently bound by comparable contractual obligations.


Risks:


The proposed rule would allow DOE to assess penalties as directed by 
Congress for noncompliance. Therefore, contractors will be put at risk 
if they violate the safety and health requirements of the rule. The 
proposed rule may also reduce the injuries and illnesses of workers due 
to increased emphasis on complaint programs.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            68 FR 68276                                    12/08/03
NPRM Comment Period End                                        02/06/04
NPRM Suspension 69 FR 9277                                     02/27/04
Supplemental NPRM                                              12/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Additional Information:


A Notice of Suspension was issued on 02/27/2004 to allow time for the 
Department to consult with the Defense Nuclear Facilities Safety Board 
(DNFSB) in order to resolve its concerns.


Agency Contact:
Bill McArthur
Department of Energy
1000 Independence Avenue, SW.
Washington, DC 20585
Phone: 301 930-9674
RIN: 1901-AA99
_______________________________________________________________________

DOE--ENDEP

                              -----------

                            FINAL RULE STAGE

                              -----------




40. RADIATION PROTECTION OF THE PUBLIC AND THE ENVIRONMENT
Priority:


Other Significant


Legal Authority:


42 USC 2201; 42 USC 7191


CFR Citation:


10 CFR 834


Legal Deadline:


None


Abstract:


This action would add a new 10 CFR 834 to DOE's regulations 
establishing a body of rules setting forth the basic requirements for 
ensuring radiation protection of the public and environment in 
connection with DOE nuclear activities. These requirements stem from 
the Department's ongoing effort to strengthen the protection of health, 
safety, and the environment from the nuclear and chemical hazards posed 
by these DOE activities. Major elements of the proposal include a dose 
limitation system for protection of the public; requirements for liquid 
discharges; reporting and monitoring requirements; and residual 
radioactive material requirements.


Statement of Need:


The purpose of this rule is to ensure that the Department's obligation 
to protect health and safety is fulfilled and to provide, if needed, a 
basis for the imposition of civil and criminal penalties consistent 
with the Price-Anderson Amendments Act of 1988. This action is 
consistent with the Department's commitment to the issuance of nuclear 
safety requirements using notice and comment rulemaking.


Summary of Legal Basis:


Under the Atomic Energy Act of 1954, as amended, the Department of 
Energy has the authority to regulate activities at facilities under its 
jurisdiction. The Department is committed to honoring its obligation to 
ensure the health and safety of the public and workers affected by its 
operations and the protection of the environs around its facilities.


Alternatives:


The Department could continue to impose nuclear safety requirements 
through directives made applicable to DOE contractors through the terms 
of their contracts.


Anticipated Cost and Benefits:


The incremental costs of the proposed rules should be minimal because 
contractors are currently bound by comparable contractual obligations. 
Full compliance by contractors with nuclear safety standards will 
result in substantial societal benefits.


Risks:


This rulemaking should reduce the risk of nuclear safety problems by 
clarifying safety requirements applicable to DOE contractors and 
improving compliance.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            58 FR 16268                                    03/25/93
Second NPRM     60 FR 45381                                    08/31/95
Conform to Related EPA Regulation                              09/00/05
Final Action                                                   06/00/06

[[Page 72716]]

Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


Federal


Additional Information:


The Environmental Protection Agency (EPA) is considering revising the 
Federal Guidance for Radiation Protection of the Public. This 
Presidential-level guidance would refine the radiation protection and 
dose limitation framework for the public, and may include numerical 
Radiation Protection Goals (i.e., dose limits). Because it is DOE's 
policy to be consistent with Federal radiation protection policy, the 
Department is adjusting the schedule for part 834 in anticipation of 
revised Federal Guidance and will issue the rule following EPA action 
on the guidance. This will allow DOE to be consistent with the most 
current Presidential-level guidance upon its release.


Agency Contact:
Andrew Wallo III
Director, Office of Air, Water and Radiation Protection, Policy and 
Guidance
Department of Energy
Office of Environmental Guidance
1000 Independence Avenue SW.
Washington, DC 20585
Phone: 202 586-4996
RIN: 1901-AA38
BILLING CODE 6450-01-S

[[Page 72717]]


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)



Statement of Regulatory Priorities
 The Department of Health and Human Services (HHS) is responsible for a 
broad range of programs designed to protect and promote the health and 
the social and economic well being of the American public. These 
programs especially affect some of the Nation's most vulnerable 
populations, including children, the elderly, and persons with 
disabilities. And, in one way or another, HHS' activities touch the 
lives of virtually every person in our country, citizens and non-
citizens alike.
 HHS' programs and activities include: Medicare, Medicaid, support for 
public health preparedness, biomedical research, substance abuse and 
mental health treatment, assurance of safe and effective drugs and 
other medical products, food safety, financial assistance to low income 
families, Head Start, services to older Americans, and direct health 
services delivery. These programs and services are essential to the 
well being of tens of millions of Americans across our country--people 
of every age, in every location, and in every walk of life.
 To improve the administration and conduct of these programs and 
activities, Secretary Thompson has made it clear that the Department 
must develop and issue regulations in a culture of responsiveness, 
where listening and responding to those we serve and those we regulate 
is the cornerstone. From health promotion and disease prevention to 
public health preparedness to food safety, the Secretary is committed 
to widening communication with consumers, beneficiaries, and all 
regulated entities. Furthermore, the Secretary wishes to ensure that 
all HHS regulations are readily understandable, are clear and concise, 
and grounded both in pertinent law and common sense.
FY 2005 Regulatory Themes
 The Secretary has adopted four overarching regulatory themes for FY 
2005:
 modernizing Medicare;
 improving the Nation's ability to prepare for and/or respond 
            to public health emergencies and disasters;
 reducing medical errors and enhancing patient safety; and
 protecting America's consumers.
 Most of the Department's regulatory priorities for this fiscal year 
will fall under these themes (see the listing below). It should be 
noted, however, that the Secretary's overall priorities go beyond these 
categories and include, for example, increasing the percentage of the 
Nation's children and adults with access to regular health care; 
motivating American adults to gain the benefits of physical activity; 
enhancing the capacity and productivity of the Nation's health-science 
research enterprise; and supporting efforts to increase the 
independence of low-income families, the disabled, and older Americans.
Modernizing Medicare
 On December 8, 2003, President Bush signed into law the Medicare 
Prescription Drug, improvement and Modernization Act of 2003 (MMA). 
This landmark legislation provides seniors and people living with 
disabilities with a prescription drug benefit, more choices, and better 
benefits under Medicare, and many other administrative and programmatic 
changes, the result of which is the most significant improvement to 
senior health care in nearly 40 years. Secretary Thompson announced in 
July 2003 proposed regulations to implement the prescription drug 
benefit, as well as new health plan choices, improved health care for 
rural America, and improved preventive care benefits. Bringing these 
proposals to completion is among the Secretary's highest priorities. 
The prescription drug benefit will allow all Medicare beneficiaries to 
enroll in drug coverage through a prescription drug plan or Medicare 
health plan, with Medicare paying for 75 percent of the premium. 
Additional benefits for Medicare beneficiaries with limited means will 
cover, on average, 95 percent of their drug costs. The new benefits 
also will provide new protections for retirees who currently receive 
drug coverage through their employers or unions. All the new Medicare 
benefits are voluntary, as seniors can choose to keep their existing 
traditional coverage.
 Also, the following regulatory actions, supported by older statutory 
authority, will also effect important improvements in Medicare:
 a final rule to establish national and local coverage-
            determination appeals processes; standardized appeals 
            processes will allow beneficiaries to challenge coverage 
            policies that could otherwise prevent legitimate claim 
            payments;
 two regulatory proposals to establish clearer performance 
            standards under Medicare for Organ Procurement 
            Organizations, and a new mechanism for reapproval of Organ 
            Transplant centers; and
 a proposed rule under which current requirements for Medicare 
            reimbursement for services to persons with End Stage Renal 
            Disease would be completely overhauled and simplified.
Improving the Department's Ability to Respond to Emergencies and 
Disasters
 HHS is responsible for directing and coordinating the medical and 
public health response to terrorism, natural disasters, major 
accidents, and other events that can result in mass casualties. Timely 
and well-focused responses to such events are key to limiting death and 
injury. The Department and its partners must be able to react quickly, 
and tailor responses to the specific emergency without being encumbered 
by counter-productive activities.
 Regulations in the Plan designed to help ensure that HHS has 
appropriate authority and flexibility to address emergencies and 
disasters include:
 three final rules to improve readiness to respond to threats 
            of food-related bioterrorism, by:
 requiring prior notification to the Food and Drug 
            Administration (FDA) of all food importation to the United 
            States,
 requiring owners or operators of domestic or foreign 
            facilities that manufacture/process, pack, or hold food for 
            human or animal consumption in the United States to 
            register the facility with the FDA; and
 requiring the maintenance of food-handling records identifying 
            the immediate source from which a wholesale food facility 
            received a food shipment as well as the shipment's 
            immediate subsequent recipient, assisting FDA in addressing 
            credible threats of serious adverse health consequences;
 a proposed rule reorganizing current FDA regulations requiring 
            registration of drug establishments, enabling the agency to 
            quickly identify firms that manufacture a specific product 
            or ingredient that may be needed during a national 
            emergency; and
 a proposed rule providing for an exception from the general 
            requirement for informed consent in the use of 
            investigational devices to identify chemical, biological, 
            radiological, or nuclear agents in a potential terrorist 
            threat or other public health emergency.

[[Page 72718]]

Reducing Medical Errors and Enhancing Patient Safety
 Medical errors and other patient safety risks have been the subject of 
many recent studies and reports. The Secretary has directed that 
actions be taken to reduce these risks. Regulatory actions included in 
the Plan under this theme include:
 a final rule requiring that drug product labels contain a 
            toll-free number for use in reporting adverse events 
            associated with the use of that product;
 a final rule requiring improvements in the format and content 
            requirements of the ``professional'' labeling of drug 
            products, enabling health care practitioners to prescribe 
            drugs more safely;
 a final rule requiring that blood establishments follow 
            written procedures (often called ``lookback'') for 
            appropriate action when it is determined that blood or 
            blood components are at increased risk for transmitting 
            hepatitis C virus infection.
Protecting America's Consumers
 Consumer health and safety is a major concern for the public and the 
Secretary. Consumers are inundated each year with an availability of 
new products and ingredients. Every year, tens of thousands of 
Americans become sick and some die from foodborne pathogens, and the 
size of vulnerable populations (e.g., the elderly and those with 
compromised immune systems) is growing. The Secretary is especially 
interested in actions that enhance safety associated with the 
production of food, or provide better nutrition information to American 
consumers.
 Regulations under this theme include:
 a final rule to standardize the manufacturing and packaging of 
            dietary supplements;
 a final rule to strengthen safety requirements for the storage 
            and distribution of eggs;
 a group of actions to further strengthen existing safeguards 
            that protect consumers against the agent that causes bovine 
            spongiform encephalopathy (``mad cow disease`), and
 two advance notices of proposed rulemaking that request 
            information from the public regarding better labeling of 
            the caloric content of food products.
Public Comments and Reactions
 The Secretary welcomes comments not only on specific regulations as 
they are published in the Federal Register, but also on the overarching 
themes he has established. Such comments, as well as suggestions for 
regulatory improvements and initiatives, should be sent to Secretary 
Tommy G. Thompson, c/o Ann C. Agnew, Executive Secretary to the 
Department, Room 603, Hubert H. Humphrey Building, 200 Independence 
Avenue SW., Washington, DC 20201.
REGULATIONS BY THEME
(parentheses contain RIN numbers)
Modernizing Medicare
Medicare Prescription Drug Benefit--MMA Title I (0938-AN08)
Medicare Advantage Program--MMA Title II (0938-AN06)
Revisions to the Review and Approval of National Accreditation 
Organizations for Deeming Authority (0939-AN62)
Organ Procurement Organizations: Conditions for Coverage (0938-AK81)
End Stage Renal Disease: Conditions for Coverage (0938-AG82)
Requirements for Approval of Transplant Centers To Perform Transplants 
(0938-AHI7)
Improving the Nations Ability to Respond to Emergencies and Disasters
Prior Notice of Imported Food Under the Public Health Security and 
Bioterrorism Preparedness and Response Act (0910-AC41)
Registration of Food and Animal Facilities (0910-AC40)
Establishment and Maintenance of Records To Identify Immediate Previous 
Source and Immediate Subsequent Recipient of Foods (0910-AC39)
Exception From General Requirements for Informed Consent; Request for 
Comments and Information (0910-AC25)
Foreign and Domestic Establishment Registration and Listing 
Requirements for Drugs and Biologics (0910- AA49)
Reducing Medical Errors and Enhancing Patient Safety
Toll-Free Number for Reporting Adverse Events on Labeling For Human 
Drugs (0910-AC35)
Revised Requirements on Content and Format of Labeling for Human 
Prescription Drugs and Biological Products (0910-AA94)
CGMPs for Blood and Blood Components: Notification of Cosignees and 
Transfusion Recipients Receiving Blood Components at Increase Risk of 
Transmitting Hepatitis C Virus (Lookback)
Current Good Tissue Practice for Manufacturers of Human Cells, Tissues 
and Cellular and Tissue-Based Products (0910-AB28)
Protecting America's Consumers
Use of Materials Derived From Cattle In Human and Animal Medical 
Products (0910-AF54)
Requirements for Human and Animal Medical Products Manufactured From, 
Processed With, or Otherwise Containing, Material From Cattle (0910-
AF55)
Use of Materials Derived From Cattle in Human Food and Cosmetics (0910- 
AF47)
Recordkeeping Requirements for Human Food and Cosmetics Manufactured 
From, Processed With, or Otherwise Containing Material From Cattle 
(0910- AF48)
Substances Prohibited From Use in Animal Food or Feed (0910- AF-46)
Food Labeling; Prominence of Calories (0910- AF22)
Food Labeling; Serving Sizes (0910-AF23)
Use of Ozone-Depleting Substances: Removal of Essential-Use 
Designation; Albuterol (0910-AF18)
Control of Salmonella Enteritidis in Shell Eggs During Production And 
Retail (0910-AC14)
Current Good Manufacturing Practices for Manufacturing, Packing, or 
Holding Dietary Ingredients and Dietary Supplements (0910-AB88)
_______________________________________________________________________

HHS--Food and Drug Administration (FDA)

                              -----------

                             PRERULE STAGE

                              -----------




41. FOOD LABELING; PROMINENCE OF CALORIES
Priority:


Other Significant. Major status under 5 USC 801 is undetermined.


Unfunded Mandates:


Undetermined


Legal Authority:


21 USC 321; 21 USC 343; 21 USC 371


CFR Citation:


21 CFR 101.9

[[Page 72719]]

Legal Deadline:


None


Abstract:


In response to the Report of the Working Group on Obesity (OWG) that 
FDA issued on March 12, 2004, the agency will issue an advance notice 
of proposed rulemaking (ANPRM) in its efforts to combat the Nation's 
obesity problem. The ANPRM will request comments on ways to give more 
prominence to ``calories'' on the food label.


Statement of Need:


The Nation is currently facing a major long-term public health crisis. 
This trend toward overweight and obesity has accelerated during the 
past decade and is well documented by numerous scientific analyses. In 
1999-2000, 64 percent of U.S. adults were overweight, increased from 56 
percent when surveyed in 1988-1994; 30 percent of adults were obese, 
increased from 23 percent in the earlier survey. Among children age 6 
through 19 years, 15 percent were overweight, compared with 10 percent 
to 11 percent in the earlier survey. Overweight and obesity are 
associated with increased morbidity and mortality. It is estimated that 
about 400,000 deaths per year may be attributed to obesity, and 
overweight and obesity increase the risk for coronary heart disease, 
type 2 diabetes, and certain cancers. The total economic cost of 
obesity in the United States is up to $117 billion per year, including 
more than $50 billion in avoidable medical costs, more than 5 percent 
of total annual health care expenditures. Fundamentally, overweight and 
obesity represents an imbalance between energy intake (e.g., calorie 
intake) and energy output (expended both as physical activity and 
metabolic activity).


Summary of Legal Basis:


Section 403(q)(1)(C) of the Federal Food, Drug, and Cosmetic Act (21 
USC 343) provides that certain foods under FDA's jurisdiction bear 
nutrition information that provides for, among other things, the total 
calories served from any source and the total number of calories 
derived from total fat in each serving size or other unit of measure. 
This ANPRM is soliciting recommendations on ways to give more 
prominence to caloric information on the food label.


Alternatives:


Possible alternatives to this advance notice of proposed rulemaking 
are: 1) do not amend certain provisions of the nutrition labeling 
regulations to give more prominence to calories on the food label; or 
2) rely on industry to voluntarily give more prominence to ``calories'' 
on the food label.


Anticipated Cost and Benefits:


If rulemaking results from this ANPRM, the rule would generate costs 
because it would require firms to reformulate food labels. Benefits of 
any rulemaking resulting from this ANPRM, depends on how consumers and 
producers respond to any changes in calorie labeling.


Risks:


Attention to caloric intake is a key element of weight control since 
weight loss and weight management are dependent on caloric balance. 
Increasing the prominence of caloric information on food labels is one 
way to provide consumers with information about their caloric intake.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM                                                          12/00/04
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Agency Contact:
Jill Kevala
Chemist
Department of Health and Human Services
Food and Drug Administration
HFS-830, Center for Food Safety and Applied Nutrition
5100 Paint Branch Parkway
College Park, MD 20740
Phone: 301 436-1450
Fax: 301 436-2636
Email: [email protected]
RIN: 0910-AF22
_______________________________________________________________________

HHS--FDA



42. FOOD LABELING; SERVING SIZES OF PRODUCTS THAT CAN REASONABLY BE 
CONSUMED AT ONE EATING OCCASION; UPDATING OF REFERENCE AMOUNTS 
CUSTOMARILY CONSUMED; APPROACHES FOR RECOMMENDING SMALLER PORTION SIZES
Priority:


Other Significant. Major status under 5 USC 801 is undetermined.


Legal Authority:


21 USC 321; 21 USC 343; 21 USC 371


CFR Citation:


21 CFR 101.9(b); 21 CFR 101.12


Legal Deadline:


None


Abstract:


In response to the Report of the Working Group on Obesity (OWG) that 
FDA issued on March 12, 2004, the agency will issue an advance notice 
of proposed rulemaking (ANPRM) in its efforts to combat the Nation's 
obesity problem. The ANPRM will request comments on changes to the 
agency's nutrition labeling regulations on serving size and comments on 
allowance of truthful, nonmisleading, and useful approaches for 
promoting consumption of smaller portion sizes.


Statement of Need:


The Nation is currently facing a major long-term public health crisis. 
This trend toward overweight and obesity has accelerated during the 
past decade and is well documented by numerous scientific analyses. In 
1999-2000, 64 percent of U.S. adults were overweight, increased from 56 
percent when surveyed in 1988-1994; 30 percent of adults were obese, 
increased from 23 percent in the earlier survey. Among children age 6 
through 19 years, 15 percent were overweight, compared with 10 percent 
to 11 percent in the earlier survey. Overweight and obesity are 
associated with increased morbidity and mortality. It is estimated that 
about 400,000 deaths per year may be attributed to obesity, and 
overweight and obesity increase the risk for coronary heart disease, 
type 2 diabetes, and certain cancers. The total economic cost of 
obesity in the United States is up to $117 billion per year, including 
more than $50 billion in avoidable medical costs, more than 5 percent 
of total annual health care expenditures. Fundamentally, overweight and 
obesity represents an imbalance between

[[Page 72720]]

energy intake (e.g., calorie intake) and energy output (expended both 
as physical activity and metabolic activity).


Summary of Legal Basis:


Section 403(q)(1)(A)(i) of the Federal Food, Drug, and Cosmetic Act (21 
USC 343 (q)(1)(A)(i)) provides that certain foods under FDA's 
jurisdiction bear nutrition information based on a serving size that 
reflects the amount of food customarily consumed and is expressed in a 
common household measure appropriate to the food. This ANPRM is 
soliciting recommendations on ways to amend certain provisions of its 
nutrition labeling regulations concerning serving size


Alternatives:


Possible alternatives to this advance notice of proposed rulemaking 
are: (1) do not amend certain serving size provisions of the nutrition 
labeling regulations, particularly on packaged products that can be 
readily consumed at one eating occasion, but that indicate they 
represent more than one serving; or (2) rely on industry to voluntarily 
revise their labels to clarify that, particularly for packaged products 
that can be readily consumed at one eating occasion, that there is more 
than one serving in the package.


Anticipated Cost and Benefits:


If rulemaking results from this ANPRM, the rule would generate costs 
because it would require firms to relabel some food products, in 
addition to potential reformulation and testing costs. Benefits of any 
rulemaking resulting from this ANPRM, depends on how consumers and 
producers respond to any changes in labeling serving sizes or portion 
sizes.


Risks:


Attention to serving size is a key element of weight control since 
weight loss and weight management are dependent on the amount of food 
consumed at one eating occasion. Clarifying how serving size is 
presented on food labels is one way to provide consumers with 
information about their caloric intake.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM                                                          12/00/04
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Agency Contact:
Lori LeGault
Nutritionist
Department of Health and Human Services
Food and Drug Administration
HFS-840
5100 Paint Branch Parkway
College Park, MD 20740
Phone: 301 436-1797
Fax: 301 436-2635
Email: [email protected]
RIN: 0910-AF23
_______________________________________________________________________

HHS--FDA

                              -----------

                          PROPOSED RULE STAGE

                              -----------




43. FOREIGN AND DOMESTIC ESTABLISHMENT REGISTRATION AND LISTING 
REQUIREMENTS FOR HUMAN DRUGS, CERTAIN BIOLOGICAL DRUGS, AND ANIMAL 
DRUGS
Priority:


Other Significant


Legal Authority:


21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC 360; 
21 USC 360b; 21 USC 371; 21 USC 374; 42 USC 262; 42 USC 264; 42 USC 271


CFR Citation:


21 CFR 20; 21 CFR 201; 21 CFR 207; 21 CFR 314; 21 CFR 330; 21 CFR 514; 
21 CFR 515; 21 CFR 601; 21 CFR 607; 21 CFR 610; 21 CFR 1271


Legal Deadline:


None


Abstract:


The proposed rule would reorganize, consolidate, clarify, and modify 
current regulations at 21 CFR part 207 concerning who must register 
establishments and list human drugs, certain biological drugs, and 
animal drugs. These regulations contain information on when, how, and 
where to register drug establishments and list drugs, and what 
information must be submitted for initial registration and listing and 
for changes to registration and listing. The proposed rule would 
require that this information be submitted via the Internet into the 
FDA registration and listing database, instead of the current 
requirement to submit the information to FDA on paper forms. The 
proposed rule would also require that the NDC number appear on drug 
labels. In addition, FDA would assign the NDC number to newly listed 
drugs and take other steps to minimize the use of inaccurate NDC 
numbers on drug labels.


Statement of Need:


FDA relies on establishment registration and drug listing for 
administering its postmarketing surveillance programs, such as 
identifying firms that manufacture a specific product or ingredient 
when that product or ingredient is in short supply or needed for a 
national emergency, for example, during a bioterrorism threat. FDA also 
uses registration and listing information for administering other 
programs such as assessing user fees. FDA is taking this action to 
improve its establishment registration and drug listing system and to 
utilize the latest technology in the collection of this information. In 
addition, improving the accuracy of and requiring NDC numbers on drug 
labels would help promote the Department's bar code, medication errors, 
and electronic prescribing initiatives.


Summary of Legal Basis:


The agency has broad authority under sections 301(p), 502(o), 510, and 
701(a) of the act and sections 351 and 361 of the Public Health Service 
Act (PHS Act) to regulate certain establishments with respect to their 
submission of registration and listing information. Failure to register 
in accordance with section 510 of the act is a prohibited act under 
section 301(p) of the act. Failure to comply with section 510 of the 
act renders drugs misbranded under section 502(o) of the act.


Alternatives:


The alternatives to this rulemaking include not updating the 
registration and listing regulations and not requiring the electronic 
submission of registration and listing information. FDA originally 
published the registration regulations in 1963 and the listing 
regulations in 1973. The registration and listing paper forms that are 
currently mailed to FDA have been in use since that time. For the 
reasons stated above, and as a result of the advances in data 
collection and transmission technology, FDA believes this rulemaking is 
the preferable alternative.

[[Page 72721]]

Anticipated Cost and Benefits:


FDA estimates that the costs to industry resulting from the proposed 
rule would include annually recurring and one-time costs. The recurring 
costs would include, among other things, measures taken by registrants 
to protect the integrity of FDA's registration and listing database 
(such as the use of a unique electronic identifier). The one-time costs 
would include, among other things, additional time required to enter 
registration and listing data into FDA's database. In addition, certain 
registrants would need to convert their labeling to an electronically 
searchable format the first time they electronically list these 
products. The specific cost to FDA of developing, administering, and 
maintaining the Electronic Drug Registration and Listing System (EDRLS) 
is being calculated. EDRLS will not be ready for use until the rule is 
finalized.


FDA believes that electronic registration and listing will be less 
costly to industry in the long run than the current requirements. The 
proposed rule would require less establishment and product information 
from many registrants and savings would result from not having to 
process paper copies of the registration and listing forms. The 
electronic registration and listing process would also enable 
registrants to receive on-screen feedback if the information submitted 
is not complete, reducing errors and the time and cost of communicating 
back and forth with FDA. Information search and retrieval time will 
also be reduced for FDA, allowing for quicker agency response time.


The proposal would make the regulations more user-friendly and would 
make the registration and listing process easier by incorporating the 
use of the Internet to submit all information. The proposal would 
improve the ability to identify and catalogue marketed drugs by helping 
to eliminate inaccurate NDC numbers on drug labels.


Risks:


None


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           04/00/05
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Howard P. Muller
Office of Regulatory Policy
Department of Health and Human Services
Food and Drug Administration
Suite 3037 (HFD-7)
Center for Drug Evaluation and Research
5515 Security Lane
Suite 1101 (HFD-7)
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]
RIN: 0910-AA49
_______________________________________________________________________

HHS--FDA



44.  SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


21 USC 321; 21 USC 342; 21 USC 343; 21 USC 349; 21 USC 371


CFR Citation:


21 CFR 589.2001


Legal Deadline:


None


Abstract:


The Food and Drug Administration (FDA) is proposing to amend its 
regulations to prohibit the use of certain cattle origin materials in 
the food or feed of all animals to help strengthen existing safeguards 
to prevent the spread of bovine spongiform encephalopathy (BSE) in U.S. 
cattle. The discovery of a BSE-positive dairy cow in December 2003 has 
caused FDA to review its policies for prevention of BSE which resulted 
in this rulemaking.


Statement of Need:


In December 2003, the U.S. Department of Agriculture (USDA) announced a 
positive case of BSE in a dairy cow in Washington State. Subsequent 
epidemiological investigations confirmed that the infected cow was born 
and most likely became infected in Alberta, Canada, prior to Canada's 
1997 implementation of a ban on feeding mammalian protein to ruminants. 
This case followed the identification of BSE in a single cow in 
Alberta, Canada, in May 2003.


In response to the identification of these BSE cases in North America, 
FDA is proposing to amend its regulations to prohibit the use of 
certain cattle origin materials in the food or feed of all animals. 
This measure will further strengthen existing safeguards designed to 
help prevent the spread of BSE in U.S. cattle.


BSE belongs to a family of diseases known as transmissible spongiform 
encephalopathies (TSEs). TSE's are fatal, progressively degenerative 
central nervous system diseases of man and other animals. TSE's 
include, among other diseases, BSE in cattle, scrapie in sheep and 
goats, chronic wasting disease (CWD) in deer and elk, and Creutzfeldt-
Jakob disease (CJD) in humans. There is no known treatment for these 
diseases, and there is no vaccine to prevent them. In addition, 
although validated postmortem diagnostic tests are available, there are 
no validated diagnostic tests for BSE that can be used to test for the 
disease in live animals.


In the Federal Register of July 14, 2004 (69 FR 42288), FDA and USDA 
jointly published an advance notice of proposed rulemaking (ANPRM) to 
inform the public about the recommendations made by a team of 
international BSE experts (IRT) convened by the Secretary of 
Agriculture in January 2004 and to request comments on a number of 
issues related to possible regulatory measures. Among other 
recommendations, the IRT recommended that: 1) all specified risk 
materials (SRMs) be excluded from all animal feed including pet food; 
2) cross contamination be prevented throughout thfeed chain; and 3) the 
use of all mammalian and poultry protein in ruminant feed be 
prohibited. FDA intends to consider all information received in 
response to the ANPRM prior to making a determination as to what 
measures are needed to further strengthen animal feed safeguards.


Summary of Legal Basis:


The agency is proposing these regulations under sections 402 and 701 of 
the Federal Food, Drug, and Cosmetics Act.


Alternatives:


FDA has considered four other measures that are not included in the 
proposed rule. These measures include: 1) a requirement that those 
facilities handling both prohibited materials and ruminant feeds use 
dedicated facilities or equipment for each; 2) a ban on the

[[Page 72722]]

use of poultry litter in ruminant feeds; 3) a ban on the use of blood 
and blood products in ruminant feeds; and 4) a ban on the use of what 
is commonly referred to as plate waste in ruminant feeds.


Anticipated Cost and Benefits:


The proposed regulation may be expected to require the expenditure of 
over $100 million in any one year by the private sector and may have a 
significant impact on a substantial number of small entities. The 
estimated total annualized costs of the rule are the sum of the costs 
of prohibiting the list of cattle origin materials identified in the 
proposed rule.


The benefit of the proposed rule includes the elimination of much of 
the remaining risk of spreading BSE in U.S. cattle. Assuming the 
hypothetical import of five infected cattle, FDA believes that the 
proposed rule would effectively remove about 95 percent of the 
remaining risk of human exposure to BSE infected material. The U.S. 
economy may also benefit from increased exports to the extent that the 
rule persuades foreign governments to import U.S. beef products. While 
we are unable to quantify these benefits, they are potentially large, 
given the significant loss of exports resulting from the discovery of 
an infected cow in Washington State.


Risks:


BSE is an incurable disease that can affect cattle and certain other 
mammals that ingest infective material from BSE infected cattle. In 
1996, a newly recognized form of the human disease, Creutzfeldt-Jakob 
disease (CJD), referred to as variant CJD (vCJD), was reported in the 
United Kingdom. Scientific and epidemiological studies have linked vCJD 
to exposure to the BSE agent, most likely through human consumption of 
beef products contaminated with the agent that causes BSE. The 
discovery of a BSE positive dairy cow in Washington State in December 
2003, caused the Agency to review its policies for the prevention of 
the spread of BSE within the United States. The need for regulatory 
action in this case is related to the inability of the market and 
existing regulations to ensure that the risk of BSE exposure through 
animal feed is minimized to the extent possible, given that BSE could 
potentially have an enormous adverse impact on both animal and human 
health.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           69 FR 42288                                    07/14/04
ANPRM Comment Period End                                       08/13/04
NPRM                                                           02/00/05
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Burt Pritchett
Biologist
Department of Health and Human Services
Food and Drug Administration
Center for Veterinary Medicine
HFV-222
7519 Standish Place, MPN-4
Rockville, MD 20855
Phone: 240 453-6860
Fax: 240 453-6882
Email: [email protected]
RIN: 0910-AF46
_______________________________________________________________________

HHS--FDA



45.  USE OF MATERIALS DERIVED FROM CATTLE IN HUMAN AND ANIMAL 
MEDICAL PRODUCTS
Priority:


Other Significant


Legal Authority:


Not Yet Determined


CFR Citation:


21 CFR 116; 21 CFR 226.60; 21 CFR 300.200; 21 CFR 500; 21 CFR 600.16; 
21 CFR 895; 21 CFR 1271.465; 21 CFR 1271.470


Legal Deadline:


None


Abstract:


The regulation would prohibit the use of certain cattle material in the 
manufacture of human medical products and animal drugs. The rule would 
prohibit the same cattle material that is prohibited in the previous 
FDA IFR that applies to foods and cosmetics. These include certain high 
risk tissues (e.g., brain, skull, eyes, spinal cord, trigeminal 
ganglia, parts of the vertebral column, and dorsal root ganglia) from 
cattle 30 months and older, tonsils and the distal ileum as well as the 
rest of the small intestine of cattle of any age, mechanically 
separated beef, material from nonambulatory disabled cattle, and 
material from cattle not inspected and passed for human consumption. 
The prohibitions would apply only to materials derived from animals 
slaughtered after the effective dates of the rules.


Statement of Need:


FDA is taking this action in response to the finding of an adult cow, 
imported from Canada, that tested positive for BSE in the State of 
Washington. This action will minimize human exposure to materials that 
scientific studies have demonstrated are highly likely to contain the 
BSE agent in cattle infected with the disease. Scientists believe that 
the human disease variant Creutzfeldt-Jakob disease (vCJD) is likely 
caused by the consumption of products contaminated with the agent that 
causes BSE.


Summary of Legal Basis:


Undetermined.


Alternatives:


There were several alternatives considered to the rule. These same 
alternatives, plus any new ones presented in comments, will be 
considered for the final.


 No new regulation.


 Prohibit the use of prohibited cattle materials in human 
medical products and animal drugs and require access to existing 
records relevant to determine compliance.


 Prohibit the use of prohibited cattle materials in human 
medical products and animal drugs and require establishment, 
maintenance, and access to records demonstrating that prohibited cattle 
materials are not used in human food and cosmetics.


Anticipated Cost and Benefits:


FDA expects minimal costs of compliance as this rule reflects current 
practices of most affected manufacturers. The costs of this rule are 
the costs to industry of assuring that prohibited materials are not 
used in the manufacture of medical products. By reducing exposure to 
potentially infective materials, this rule will provide an additional 
safeguard against a case of vCJD occurring in humans if cattle infected 
with BSE are used in the manufacture or processing of medical products.


Risks:


The benefits of the rule will be the value of the public and health 
benefits.

[[Page 72723]]

The public and animal health benefit is the reduction in the risk of 
the human and ruminant illness associated with exposure to the agent 
that causes BSE.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           02/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Eric Flamm
Senior Policy Advisor, Office of Policy
Department of Health and Human Services
Food and Drug Administration
Office of the Commissioner
5600 Fishers Lane
Room 15-61, HF-23
Rockville, MD 20857
Phone: 301 827-0891
Fax: 301 827-4774
Email: [email protected]
RIN: 0910-AF54
_______________________________________________________________________

HHS--FDA



46.  REQUIREMENTS FOR HUMAN AND ANIMAL MEDICAL PRODUCTS 
MANUFACTURED FROM, PROCESSED WITH, OR OTHERWISE CONTAINING MATERIAL 
FROM CATTLE
Priority:


Other Significant


Legal Authority:


Not Yet Determined


CFR Citation:


21 CFR 116; 21 CFR 226.60; 21 CFR 300.200; 21 CFR 500; 21 CFR 600.16; 
21 CFR 895; 21 CFR 1271.465; 21 CFR 1271.470


Legal Deadline:


None


Abstract:


This is a companion rulemaking to FDA's rule entitled ``Use of 
Materials Derived From Cattle in Human and Animal Medical Products,'' 
to be published in the same issue of the Federal Register. The rule 
would propose recordkeeping requirements for human and animal medical 
products that contain cattle material. Manufacturers and sponsors of 
such products would have to establish and maintain records to 
demonstrate that prohibited materials were not used in their 
manufacture.


Statement of Need:


FDA is proposing recordkeeping requirements because records documenting 
the absence of prohibited cattle materials are needed by manufacturers 
and processors of human medical products and animal drugs that contain 
or are manufactured with cattle material to ensure that these products 
do not contain prohibited cattle materials. Prohibited cattle materials 
are materials that scientific studies have demonstrated are highly 
likely to contain the BSE agent in cattle infected with the disease. 
Scientists believe that the human disease variant Creutzfeldt-Jakob 
disease (vCJD) is likely caused by the consumption of products 
contaminated with the agent that causes BSE.


FDA is proposing additional restrictions for higher risk human medical 
products and for ruminant drugs to address the greater disease risk 
posed by these products should they contain any infectious material 
from a BSE-positive animal.


Summary of Legal Basis:


Undetermined.


Alternatives:


Alternatives were not specifically considered in the proposed rule with 
regard to recordkeeping requirements because it was a companion 
rulemaking to the interim final rule prohibiting the use of certain 
cattle material in human medical products and animal drugs. 
Recordkeeping alternatives were considered in the interim final rule. 
Those same alternatives, plus any new ones presented in comments, will 
be considered for the final rule.


There were several alternatives considered to the proposed additional 
restrictions. These same alternatives, plus any new ones presented in 
comments, will be considered for the final.


 No additional restrictions.


 Prohibit the use in higher risk human medical products of 
listed neural tissues from cattle 12 months and older and all cattle 
material from countries listed by APHIS as having unacceptable risk or 
incidence of BSE, and prohibit the use in ruminant drugs of those 
materials that are prohibited in ruminant feed.


Anticipated Cost and Benefits:


FDA believes this rule reflects current practices of most affected 
manufacturers. The costs of this rule are the costs to industry of 
assuring that prohibited materials are not used in the manufacture of 
medical products and of conforming with additional restrictions on the 
use of cattle material in certain medical products (implantable, etc.). 
In addition, affected manufacturers will incur costs associated with 
establishing and maintaining records to demonstrate compliance. By 
reducing exposure to potentially infective materials, this rule will 
provide an additional safeguard against a case of vCJD occurring in 
humans if cattle infected with BSE are used in the manufacture or 
processing of medical products.


Risks:


The benefits of finalizing the proposed rule with respect to its 
recordkeeping requirements are derived from the benefits of the interim 
final rule, which are the value of the public and animal health 
benefits. The benefits of finalizing the proposed rule with respect to 
its additional requirements are also the value of the public and animal 
health benefits. The public and animal health benefit is the reduction 
in the risk of the human or animal illness associated with exposure to 
the agent that causes BSE.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           02/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Federalism:


 Undetermined

[[Page 72724]]

Agency Contact:
Eric Flamm
Senior Policy Advisor, Office of Policy
Department of Health and Human Services
Food and Drug Administration
Office of the Commissioner
5600 Fishers Lane
Room 15-61, HF-23
Rockville, MD 20857
Phone: 301 827-0891
Fax: 301 827-4774
Email: [email protected]
RIN: 0910-AF55
_______________________________________________________________________

HHS--FDA

                              -----------

                            FINAL RULE STAGE

                              -----------




47. REQUIREMENTS ON CONTENT AND FORMAT OF LABELING FOR HUMAN 
PRESCRIPTION DRUGS AND BIOLOGICAL PRODUCTS
Priority:


Other Significant. Major status under 5 USC 801 is undetermined.


Legal Authority:


21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 371; 42 
USC 262


CFR Citation:


21 CFR 201


Legal Deadline:


None


Abstract:


This regulation is one component of the Secretary's initiative to 
reduce medical errors. The regulation would amend the regulations 
governing the format and content of professional labeling for human 
prescription drugs (including biological products that are regulated as 
drugs), 21 CFR 201.56 and 201.57. The regulation would require that 
such labeling include a section containing highlights of prescribing 
information, and a section containing a table of contents of 
prescribing information; reorder currently required information and 
make minor changes to its content, and establish minimum graphical 
requirements.


Statement of Need:


The current format and content requirements in sections 201.56 and 
201.57 were established in 1979 to help ensure that labeling includes 
adequate information to enable health care practitioners to prescribe 
drugs safely and effectively. However, various developments in recent 
years, such as increasing product liability and technological advances 
in drug product development, have contributed to an increase in the 
amount, detail, and complexity of labeling information. This has made 
it harder for practitioners to find specific information and to discern 
the most critical information in labeling.


FDA took numerous steps to evaluate the usefulness of labeling for 
practitioners and to determine whether, and how, its format and content 
can be improved. The agency conducted focus groups and a national 
survey of office-based physicians to ascertain how labeling is used by 
health care practitioners, what labeling information is most important 
to practitioners, and how labeling should be revised to improve its 
usefulness to practitioners.


Based on the concerns cited by practitioners in the focus groups and 
physician survey, FDA developed and tested two prototypes of revised 
labeling formats designed to facilitate access to important labeling 
information. Based on this testing, FDA developed a third revised 
prototype that it made available to the public for comment. Ten written 
comments were received on the prototype. FDA also presented the revised 
prototype at an informal public meeting held on October 30, 1995. At 
the public meeting, the agency also presented the background research 
and provided a forum for oral feedback from invited panelists and 
members of the audience. The panelists generally supported the 
prototype.


The proposed rule, published in 2000, described format and content 
requirements for prescription drug labeling that incorporate 
information and ideas gathered during this process. The agency has 
received several comments on the proposal and the comment period was 
extended until June 22, 2001.


Summary of Legal Basis:


The agency has broad authority under sections 201, 301, 501, 502, 503, 
505, and 701 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 
U.S.C. 321, 331, 351, 352, 353, 355, and 371) and section 351 of the 
Public Health Service Act (42 U.S.C. 262) to help ensure that 
prescription drugs (including biological products that are regulated as 
drugs) are safe and effective for their intended uses. A major part of 
FDA's efforts regarding the safe and effective use of drug products 
involves FDA's review, approval, and monitoring of drug labeling. Under 
section 502(f)(1) of the Act, a drug is misbranded unless its labeling 
bears ``adequate directions for use'' or it is exempted from this 
requirement by regulation. Under section 201.100 (21 CFR 201.100), a 
prescription drug is exempted from the requirement in section 502(f)(1) 
of the Act only if, among other things, it contains the information 
required, in the format specified, by sections 201.56 and 201.57.


Under section 502(a) of the Act, a drug product is misbranded if its 
labeling is false or misleading in any particular. Under section 505(d) 
and 505(e) of the Act, FDA must refuse to approve an application and 
may withdraw the approval of an application if the labeling for the 
drug is false or misleading in any particular. Section 201(n) of the 
Act provides that in determining whether the labeling of a drug is 
misleading, there shall be taken into account not only representations 
or suggestions made in the labeling, but also the extent to which the 
labeling fails to reveal facts that are material in light of such 
representations or material with respect to the consequences which may 
result from use of the drug product under the conditions of use 
prescribed in the labeling or under customary usual conditions of use.


These statutory provisions, combined with section 701(a) of the Act and 
section 351 of the Public Health Service Act, clearly authorize FDA to 
promulgate a final regulation designed to help ensure that 
practitioners prescribing drugs (including biological products) will 
receive information essential to their safe and effective use in a 
format that makes the information easier to access, read, and use.


Alternatives:


The alternatives to the final rule include not amending the content and 
format requirements in sections 201.56 and 201.57 at all, or amending 
them to a lesser extent. The agency has determined that although drug 
product labeling, as currently designed, is useful to physicians, many 
find it difficult to locate specific information in labeling, and some 
of the most frequently consulted and most important information is 
obscured by other information. In addition, the agency's research 
showed that physicians strongly support the concept of including a 
highlights section of the most important prescribing information, a 
table of contents and numbering system that permits specific

[[Page 72725]]

information to be easily located, and other requirements, such as the 
requirement for a minimum type size. Thus, the agency believes that the 
requirements in the final rule will greatly facilitate health care 
practitioners' access and use of prescription drug and biological 
product labeling information.


Anticipated Cost and Benefits:


The purpose of this rule is to make it easier for health care 
practitioners to access, read and use information in prescription drug 
labeling, thereby increasing the extent to which they rely on labeling 
to obtain information. FDA believes the revisions to the content and 
format of labeling will enhance the safe and effective use of 
prescription drug products, and in turn, reduce the number of adverse 
reactions resulting from medication errors due to misunderstood or 
wrongly applied drug information. The new requirements are important to 
the success of other initiatives aimed at improving patient care and 
decreasing the likelihood of medication errors. For example, revised 
labeling will facilitate initiatives to process, review and archive 
labeling electronically and provide a mechanism to facilitate the 
development of electronic prescribing systems.


The potential costs associated with the final rule include the cost of 
redesigning labeling for previously approved products to which the 
proposed rule would apply and submitting the new labeling to FDA for 
approval. In addition, one-time and ongoing incremental costs would be 
associated with printing the longer labeling that would result from 
additional required sections. These costs would be minimized by 
applying the amended requirements only to newer products and by 
staggering the implementation date for previously approved products.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            65 FR 81082                                    12/22/00
NPRM Comment Period End                                        03/22/01
NPRM Comment Period Reopened                                   03/30/01
NPRM Comment Period Reopening End                              06/22/01
Final Action                                                   12/00/04
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Elizabeth J. Sadove
Regulatory Counsel, Office of Regulatory Policy
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research Administration
5515 Security Lane
Suite 1101 (HFD-7)
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AA94
_______________________________________________________________________

HHS--FDA



48. SAFETY REPORTING REQUIREMENTS FOR HUMAN DRUG AND BIOLOGICAL 
PRODUCTS
Priority:


Other Significant. Major status under 5 USC 801 is undetermined.


Unfunded Mandates:


Undetermined


Legal Authority:


42 USC 216; 42 USC 241; 42 USC 242a; 42 USC 262; 42 USC 263; 42 USC 
263a to 263-n; 42 USC 264; 42 USC 300aa; 21 USC 321; 21 USC 331; 21 USC 
351 to 353; 21 USC 355; 21 USC 360; 21 USC 360b to 360j; 21 USC 361a; 
21 USC 371; 21 USC 374; 21 USC 375; 21 USC 379e; 21 USC 381


CFR Citation:


21 CFR 310; 21 CFR 312; 21 CFR 314; 21 CFR 320; 21 CFR 600; 21 CFR 601; 
21 CFR 606


Legal Deadline:


None


Abstract:


This regulation is one component of the Secretary's initiative to 
reduce medical errors. The final rule would amend the expedited and 
periodic safety reporting regulations for human drugs and biological 
products to revise certain definitions and reporting formats as 
recommended by the International Conference on Harmonisation and to 
define new terms; to add to or revise current reporting requirements; 
to revise certain reporting time frames; and propose other revisions to 
these regulations to enhance the quality of safety reports received by 
FDA.


Statement of Need:


FDA currently has safety reporting requirements in section 21 CFR 
312.32 for sponsors of investigational drugs for human use. FDA also 
has safety reporting requirements in sections 21 CFR 310.305, 314.80, 
314.98 and 600.80 and 600.81 for applicants, manufacturers, packers, 
and distributors of approved human drug and biological products. FDA 
has undertaken a major effort to clarify and revise these regulations 
to improve the management of risks associated with the use of these 
products. For this purpose, the agency is proposing to implement 
certain definitions and reporting formats and standards recommended by 
the International Conference on Harmonisation of Technical Requirements 
for Registration of Pharmaceuticals for Human Use (ICH) to provide more 
effective and efficient safety reporting to regulatory authorities 
worldwide. Currently, the United States, European Union, and Japan 
require submission of safety information for marketed drug and 
biological products using different reporting formats and different 
reporting intervals.


Summary of Legal Basis:


The agency has broad authority under sections 505 and 701 of the 
Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 355 and 371) 
and section 351 of the Public Health Service Act (42 U.S.C. 262) to 
monitor the safety of drug and biological products for human use.


Alternatives:


The alternatives to the proposal include not amending our existing 
safety reporting requirements. This alternative would be inconsistent 
with FDA's efforts to harmonize its safety reporting requirements with 
international initiatives and with its mission to protect public 
health.


Anticipated Cost and Benefits:


Manufacturers of human drug and biological products currently have 
limited incentives to invest capital and resources in standardized 
global safety reporting systems because individual firms acting alone 
cannot attain the economic gains of harmonization. This final rule 
would harmonize FDA's

[[Page 72726]]

safety reporting requirements with certain international initiatives, 
thereby providing the incentive for manufacturers to modify their 
safety reporting systems. Initial investments made by manufacturers to 
comply with the rule are likely to ultimately result in substantial 
savings to them over time.


The impact on industry includes costs associated with revised safety 
reporting and recordkeeping requirements. The benefits of the proposed 
rule are public health benefits and savings to the affected industries. 
The expected public health benefits would result from the improved 
timeliness and quality of the safety reports and analyses, making it 
possible for health care practitioners and consumers to expedite 
corrective actions and make more informed decisions about treatments. 
Savings to the affected industry would accrue from more efficient 
allocation of resources resulting from international harmonization of 
the safety reporting requirements.


Risks:


None


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            68 FR 12406                                    03/14/03
NPRM Comment Period Extended                                   06/18/03
NPRM Comment Period End                                        07/14/03
NPRM Comment Period Extension End                              10/14/03
Comment Review End                                             04/00/05
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Undetermined


Agency Contact:
Elizabeth J. Sadove
Regulatory Counsel, Office of Regulatory Policy
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research Administration
5515 Security Lane
Suite 1101 (HFD-7)
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AA97
_______________________________________________________________________

HHS--FDA



49. CURRENT GOOD TISSUE PRACTICE FOR HUMAN CELL, TISSUE, AND CELLULAR 
AND TISSUE-BASED PRODUCT ESTABLISHMENTS; INSPECTION AND ENFORCEMENT
Priority:


Other Significant


Legal Authority:


42 USC 216; 42 USC 243; 42 USC 263a; 42 USC 264; 42 USC 271


CFR Citation:


21 CFR 16; 21 CFR 1270; 21 CFR 1271


Legal Deadline:


None


Abstract:


The Food and Drug Administration (FDA) is requiring human cell, tissue, 
and cellular and tissue-based product (HCT/P) establishments to follow 
current good tissue practice (CGTP), which governs the methods used in, 
and the facilities and controls used for, the manufacture of HCT/Ps, 
recordkeeping, and the establishment of a quality program. FDA is also 
issuing regulations pertaining to labeling, reporting, inspections, and 
enforcement.


Statement of Need:


Donor screening and testing, although crucial, are not sufficient to 
prevent the transmission of disease through HCT/Ps. Each step in the 
manufacturing process needs to be controlled. Errors in labeling and 
testing records, failure to adequately clean work areas, and faulty 
packaging are examples of improper practices that could lead to a 
product capable of transmitting disease to a recipient. The agency is 
concerned about the spread of communicable disease through the use of 
such products. CGTP requirements are a fundamental component of FDA's 
risk-based approach to regulating HCT/Ps.


Summary of Legal Basis:


The Public Health Service Act (42 U.S.C. 264) authorizes FDA to 
promulgate regulations to prevent the spread of communicable diseases. 
HCT/Ps may transmit communicable diseases. The CGTP regulations are 
essential to the prevention of communicable disease transmission.


Alternatives:


An alternative to the proposed approach would be to continue with the 
use of voluntary industry standards. Reliance on industry's voluntary 
standards for good tissue practice, rather than establishing regulatory 
requirements, would not ensure uniform or consistent compliance and 
would preclude the agency's ability to effectively monitor HCT/Ps to 
ensure public health and safety.


Anticipated Cost and Benefits:


FDA has estimated that this rule would impose a total annualized cost 
of about $8 million for the entire industry. The primary beneficiaries 
of the proposed CGTP would be the patients who receive HCT/Ps. Benefits 
to patients would result from the reduced risk of communicable disease 
by avoiding product contamination through CGTP.


Risks:


FDA believes that the risks posed by requiring CGTP are minimal. In 
contrast, failure to reduce the risk of transmission of communicable 
disease through the use of HCT/Ps would jeopardize the public health.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            66 FR 1508                                     01/08/01
NPRM Comment Period End                                        05/08/01
Final Action                                                   12/00/04
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


State

[[Page 72727]]

Agency Contact:
Paula S. McKeever
Regulatory Policy Analyst
Department of Health and Human Services
Food and Drug Administration
Suite 200N (HFM-17)
Center for Biologics Evaluation and Research
1401 Rockville Pike
Rockville, MD 20852-1448
Phone: 301 827-6210
Fax: 301 827-9434
RIN: 0910-AB28
_______________________________________________________________________

HHS--FDA



50. CGMPS FOR BLOOD AND BLOOD COMPONENTS: NOTIFICATION OF CONSIGNEES 
AND TRANSFUSION RECIPIENTS RECEIVING BLOOD AND BLOOD COMPONENTS AT 
INCREASED RISK OF TRANSMITTING HCV INFECTION (LOOKBACK)
Priority:


Other Significant. Major under 5 USC 801.


Legal Authority:


21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 
USC 371; 21 USC 374; 42 USC 216; 42 USC 262; 42 USC 263a; 42 USC 264; 
21 USC 372; 21 USC 372; 21 USC 381; 42 USC 263


CFR Citation:


21 CFR 606; 21 CFR 610


Legal Deadline:


None


Abstract:


This rulemaking is one of a number of actions being taken to amend the 
biologics regulations to remove, revise, or update the regulations 
applicable to blood, blood components, and blood derivatives. These 
actions are based on FDA's comprehensive review of the biologics 
regulations and on reports by the U.S. House of Representatives 
Committee on Government Reform and Oversight's, Subcommittee on House 
Resources and Intergovernmental Relations, the General Accounting 
Office, and the Institute of Medicine, as well as on public comments. 
In this rulemaking, FDA will amend the biologics regulations to require 
that blood establishments prepare and follow written procedures for 
appropriate action when it is determined that blood and blood 
components pose an increased risk for transmitting hepatitis C virus 
(HCV) infection because they have been collected from a donor who, at a 
later date, tested reactive for evidence of HCV. The HIV lookback 
regulations will be amended for consistency.


Statement of Need:


In the Federal Register of June 22, 1999 (64 FR 33309), FDA announced 
the availability of guidance, which updated previous guidance, 
providing recommendations for donor screening and further testing for 
antibodies to HCV, notification of consignees, transfusion recipient 
tracing and notification, and counseling by physicians regarding 
transfusion with blood components at increased risk for transmitting 
HCV (these activities are often called ``lookback''). FDA believes that 
regulations should be established consistent with the recommendations, 
to assure that there is clear enforcement authority in case 
deficiencies in an establishment's lookback program are found and to 
provide clear instructions for continuing lookback activities.


Summary of Legal Basis:


The Public Health Service Act (42 U.S.C. 201 et seq.) and the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.) authorize FDA to 
regulate biological products and to ensure that the products are safe, 
pure, potent, and effective. The Public Health Service Act also 
contains authority under which FDA can promulgate regulations to 
prevent the spread of communicable diseases. This rulemaking would 
assure that appropriate action is taken when blood has been collected 
which may potentially be capable of transmitting HCV; that persons who 
have been transfused with such blood components are notified so that 
they receive proper counseling and treatment; and that infected donors 
are notified. These regulations will therefore help prevent the further 
transmission of HCV.


Alternatives:


FDA has considered permitting continued voluntary compliance with the 
recommendations that have already been issued. However, lookback will 
remain appropriate for the foreseeable future, and FDA believes that 
the procedures should be clearly established in the regulations.


Anticipated Cost and Benefits:


FDA is in the process of analyzing the costs related to the rulemaking. 
Monetary burdens will be associated with the tracing of previous 
donations of donors, quarantining in-date products, identifying the 
recipients of previous blood donations, and notifying these recipients, 
as appropriate. FDA believes that these costs will be more than 
balanced by the public health benefits, including benefits related to 
the notification of past transfusion recipients who may be unaware that 
they may be infected with HCV.


Risks:


FDA believes that there are minimum risks posed by requiring that 
appropriate lookback procedures for HCV be prepared and followed.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            65 FR 69377                                    11/16/00
NPRM Comment Period End                                        02/14/01
Final Action                                                   03/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Paula S. McKeever
Regulatory Policy Analyst
Department of Health and Human Services
Food and Drug Administration
Suite 200N (HFM-17)
Center for Biologics Evaluation and Research
1401 Rockville Pike
Rockville, MD 20852-1448
Phone: 301 827-6210
Fax: 301 827-9434
Related RIN: Related to 0910-AB26
RIN: 0910-AB76
_______________________________________________________________________

HHS--FDA



51. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR 
HOLDING DIETARY INGREDIENTS AND DIETARY SUPPLEMENTS
Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


This action may affect the private sector under PL 104-4.

[[Page 72728]]

Legal Authority:


21 USC 321; 21 USC 342; 21 USC 343; 21 USC 348; 21 USC 371; 21 USC 374; 
21 USC 381; 21 USC 393; 42 USC 264


CFR Citation:


21 CFR 111


Legal Deadline:


None


Abstract:


The Food and Drug Administration proposed in the Federal Register of 
March 13, 2003 (68 FR 12158), current good manufacturing practice 
(CGMP) regulations for dietary ingredients and dietary supplements. The 
proposed rule was published to establish the minimum CGMPs necessary to 
ensure that, if firms engage in activities related to manufacturing, 
packaging, or holding dietary ingredients of dietary supplements, they 
do so in a manner that will not adulterate and misbrand such dietary 
ingredients or dietary supplements. FDA also proposed to require 
manufacturers to evaluate the identity, purity, quality, strength, and 
composition of their dietary ingredients and dietary supplements. The 
proposed rule also responds to concerns that such regulations are 
necessary to ensure that consumers are provided with dietary supplement 
products which have not been adulterated as a result of manufacturing, 
packing, or holding, e.g., which have the identity and provide the 
quantity of dietary ingredients declared in labeling.


Statement of Need:


FDA intends to publish a final rule to establish CGMP for dietary 
supplements and dietary ingredients for several reasons. First, FDA is 
concerned that some firms may not be taking appropriate steps during 
the manufacture of dietary supplements and dietary ingredients to 
ensure that products are not adulterated as a result of manufacturing, 
packing, or holding. There have been cases of misidentified ingredients 
harming consumers using dietary supplements. FDA is also aware of 
products that contain potentially harmful contaminants because of 
apparently inadequate manufacturing controls and quality control 
procedures. The agency believes that a system of CGMPs is the most 
effective and efficient way to ensure that these products will not be 
adulterated during manufacturing, packing, or holding.


Summary of Legal Basis:


If CGMP regulations were adopted by FDA, failure to manufacture, pack, 
or hold dietary supplements or dietary ingredients under CGMP 
regulations would render the dietary supplement or dietary ingredients 
adulterated under section 402(g) of the Act.


Alternatives:


The two principal alternatives to comprehensive CGMPs are end product 
testing and Hazard Analysis Critical Control Points (HACCP). The agency 
asked whether different approaches may be better able to address the 
needs of the broad spectrum of firms that conduct one or more distinct 
operations, such as the manufacture of finished products, or solely the 
distribution and sale of finished products at the wholesale or retail 
level.


Anticipated Cost and Benefits:


The costs of the regulation will include the value of resources devoted 
to increased sanitation, process monitoring and controls, testing, and 
written records. The benefits of the proposed regulation are to improve 
both product safety and quality. We estimate that the proposed 
regulation will reduce the number of sporadic human illnesses and rare 
catastrophic illnesses from contaminated products. The current quality 
of these products is highly variable, and consumers lack information 
about the potential hazards and variable quality of these products. The 
product quality benefits occur because there will be fewer product 
recalls and more uniform products will reduce consumer search for 
preferred quality products. The proposed rule will have a significant 
impact on a substantial number of small businesses, so it will be 
significant under the Regulatory Flexibility Act. We anticipate that 
small businesses will bear a proportionately larger cost than large 
businesses.


Risks:


Any potential for consumers to be provided adulterated (e.g., 
contaminated with industrial chemicals, pesticides, microbial 
pathogens, or dangerous misidentified ingredients or toxic components 
of ingredients) products must be considered a very serious risk because 
of the possibility that such contamination could be widespread, 
affecting whole segments of the population, causing some severe long-
term effects and even loss of life. Dietary supplements are used by a 
large segment of the American public. Moreover, they are often used by 
segments of the population that are particularly vulnerable to 
adulterated products, such as the elderly, young children, pregnant and 
nursing women, and persons who may have serious illnesses or are taking 
medications that may adversely interact with dietary supplements. FDA 
has adopted or proposed manufacturing controls for a number of foods 
and commodities that present potential health hazards to consumers if 
not processed properly, including seafood, juice products, and fruits 
and vegetables, and it is appropriate that FDA consider whether 
manufacturing controls are necessary to assure consumers that dietary 
supplements are not adulterated during the manufacturing, packing, or 
holding process.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           62 FR 5700                                     02/06/97
ANPRM Comment Period End                                       06/06/97
NPRM            68 FR 12157                                    03/13/03
NPRM Comment Period End                                        08/11/03
Final Action                                                   03/00/05
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Agency Contact:
Linda Kahl
Consumer Safety Officer
Department of Health and Human Services
Food and Drug Administration
HFS-206
Center for Food Safety and Applied Nutrition
5100 Paint Branch Parkway
College Park, MD 20740
Phone: 202 418-3101
Fax: 202 418-3131
Email: [email protected]
RIN: 0910-AB88
_______________________________________________________________________

HHS--FDA



52. PREVENTION OF SALMONELLA ENTERITIDIS IN SHELL EGGS
Priority:


Economically Significant. Major under 5 USC 801.

[[Page 72729]]

Unfunded Mandates:


This action may affect the private sector under PL 104-4.


Legal Authority:


21 USC 321; 21 USC 342; 21 USC 371; 21 USC 381; 21 USC 393; 42 USC 243; 
42 USC 264; 42 USC 271; . . .


CFR Citation:


21 CFR 16; 21 CFR 116; 21 CFR 118


Legal Deadline:


None


Abstract:


In July 1999, the Food and Drug Administration (FDA) and the Food 
Safety Inspection Service (FSIS) committed to developing an action plan 
to address the presence of salmonella enteritidis (SE) in shell eggs 
and egg products using a farm-to-table approach. FDA and FSIS held a 
public meeting on August 26, 1999, to obtain stakeholder input on the 
draft goals, as well as to further develop the objectives and action 
items for the action plan. The Egg Safety Action Plan was announced on 
December 11, 1999. The goal of the Action Plan is to reduce egg-related 
SE illnesses by 50 percent by 2005 and eliminate egg-related SE 
illnesses by 2010.


The Egg Safety Action Plan consists of eight objectives covering all 
stages of the farm-to-table continuum as well as support functions. On 
March 30, 2000 (Columbus, OH), April 6, 2000 (Sacramento, CA), and July 
31, 2000 (Washington, DC), joint public meetings were held by FDA and 
FSIS to solicit and discuss information related to the implementation 
of the objectives in the Egg Safety Action Plan.


In accordance with discussions at the public meetings, FDA intends to 
publish a proposed rule to require that shell eggs be produced under a 
plan that is designed to prevent transovarian SE from contaminating 
eggs at the farm during production.


FDA intends to discuss in its proposal certain provisions of the 1999 
Food Code that are relevant to how eggs are handled, prepared, and 
served at certain retail establishments. In addition, the agency plans 
to consider whether it should require provisions for certain retail 
establishments that serve populations most at risk of egg-related 
illness (i.e., the elderly, children, and the immunocompromised).


Statement of Need:


FDA is proposing regulations as part of the farm-to-table safety system 
for eggs outlined by the President's Council on Food Safety in its Egg 
Safety Action Plan. FDA intends to propose these regulations because of 
the continued reports of outbreaks of foodborne illness and death 
caused by SE that are associated with the consumption of shell eggs. 
The agency believes these regulations can have significant effect in 
reducing the risk of illness from SE-contaminated eggs and will 
contribute significantly to the interim public health goal of the Egg 
Safety Action Plan of a 50 percent reduction in egg-related SE illness 
by 2005.


Summary of Legal Basis:


FDA's legal basis for the proposed rule derives in part from sections 
402(a)(4), and 701(a) of the Federal Food, Drug and Cosmetic Act (the 
Act) ((21 U.S.C. 342(a)(4) and 371(a)). Under section 402(a)(4) of the 
Act, a food is adulterated if it is prepared, packed, or held in 
insanitary conditions whereby it may have been contaminated with filth 
or may have been rendered injurious to health. Under section 701(a) of 
the Act, FDA is authorized to issue regulations for the efficient 
enforcement of the Act. FDA also intends to rely on section 361 of the 
Public Health Service Act (PHS Act) (42 U.S.C. 264), which gives FDA 
authority to promulgate regulations to control the spread of 
communicable disease.


Scientific reports in published literature and data gathered from 
existing voluntary egg quality assurance programs indicate that 
measures designed to prevent SE from entering a poultry house (e.g., 
rodent/pest control, use of chicks from SE-monitored breeders, and 
biosecurity programs) can be very effective in reducing SE-
contamination of eggs and related foodborne illness.


Alternatives:


There are several alternatives that the agency intends to consider in 
the proposed rule. The principal alternatives include: (1) no new 
regulatory action; (2) alternative testing requirements; (3) 
alternative on-farm prevention measures; (4) alternative retail 
requirements; and (5) HACCP.


Anticipated Cost and Benefits:


The benefits from the proposed regulation to control Salmonella 
Enteritidis in shell eggs on the farm derive from better farming 
practices. Improved practices reduce contamination and generate 
benefits measured as the value of the human illnesses prevented. FDA 
has produced preliminary estimates of costs and benefits for a number 
of options. The mitigations considered include on-farm rodent control, 
changes in retail food preparation practices, diversion of eggs from 
infected flocks to pasteurization, record keeping, refrigeration, and 
feed testing. The actual costs and benefits of the proposed rule will 
depend upon the set of mitigations chosen and the set of entities 
covered by the proposed rule.


Risks:


Any potential for contamination of eggs with SE and its subsequent 
survival or growth must be considered a very serious risk because of 
the possibility that such contamination, survival, and growth could 
cause widespread foodborne illness, including some severe long-term 
effects and even loss of life. FDA made a decision to publish a 
proposed rule that would include SE prevention measures, based on a 
considerable body of evidence, literature, and expertise in this area. 
In addition, this decision was also based on the USDA risk assessment 
on SE in shell eggs and egg products and the identified public health 
benefits associated with controlling SE in eggs at the farm and retail 
levels.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            69 FR 56824                                    09/22/04
Final Action                                                   09/00/05
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Undetermined


Agency Contact:
Rebecca Buckner
Consumer Safety Officer
Department of Health and Human Services
Food and Drug Administration
HFS-306
Center for Food Safety and Applied Nutrition
5100 Paint Branch Parkway
HFS-366
College Park, MD 20740
Phone: 301 436-1486
Fax: 301 436-2632
Email: [email protected]
RIN: 0910-AC14

[[Page 72730]]

_______________________________________________________________________

HHS--FDA



53. TOLL-FREE NUMBER FOR REPORTING ADVERSE EVENTS ON LABELING FOR HUMAN 
DRUGS
Priority:


Other Significant


Legal Authority:


21 USC 355b


CFR Citation:


21 CFR 201; 21 CFR 208; 21 CFR 209


Legal Deadline:


Final, Statutory, January 4, 2003.


Abstract:


To require the labeling of human drugs approved under section 505 of 
the Federal Food, Drug, and Cosmetic Act to include a toll-free number 
for reports of adverse events, and a statement that the number is to be 
used for reporting purposes only and not to receive medical advice.


Statement of Need:


Consumers may not be aware of FDA's adverse event reporting program 
under Medwatch. This requirement will promote FDA's mission to protect 
the public health by informing consumers of FDA's Medwatch system.


Summary of Legal Basis:


Section 17 of the Best Pharmaceuticals for Children Act (BPCA) requires 
a final rule to issue within one year of the date of its enactment on 
January 4, 2002.


Alternatives:


This rule is required by section 17 of the BPCA. FDA has considered 
alternatives within the scope of the statutory requirements, in 
particular, ways to reach the broadest consumer audience and to 
minimize costs to the pharmacy profession.


Anticipated Cost and Benefits:


Anticipated costs are to drug manufacturers and authorized dispensers 
of drug products, including pharmacies. The BPCA contains a provision 
requiring the Secretary to seek to minimize the cost to the pharmacy 
profession. Anticipated benefits are to obtain information about 
adverse events from consumers, which may inform FDA of trends in 
reported adverse events and result in a review of the safety and/or 
effectiveness of particular drug products on the market.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            69 FR 21778                                    04/22/04
NPRM Comment Period End                                        07/21/04
Final Action                                                   05/00/05
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Carol Drew
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Suite 3037 (HFD-7)
Center for Drug Evaluation and Research
5515 Security Lane
Suite 1101 (HFD-7)
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AC35
_______________________________________________________________________

HHS--FDA



54. ESTABLISHMENT AND MAINTENANCE OF RECORDS PURSUANT TO THE PUBLIC 
HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF 2002
Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


This action may affect the private sector under PL 104-4.


Legal Authority:


PL 107-188, sec 306


CFR Citation:


21 CFR 1


Legal Deadline:


None


Abstract:


This rulemaking is one of a number of actions being taken to improve 
FDA's ability to respond to threats of bioterrorism. Section 414(b) of 
the Federal Food, Drug, and Cosmetic Act (FFDCA), which was added by 
section 306 of the Public Health Security and Bioterrorism Preparedness 
and Response Act of 2002 (the Act), authorizes the Secretary, through 
FDA, to promulgate final regulations by December 12, 2003. The Act 
authorizes regulations that require the establishment and maintenance 
of records, for not longer than two years, that would allow the 
Secretary to identify the immediate previous sources and the immediate 
subsequent recipients of food, including its packaging. The required 
records would be those that are needed by FDA in order to address 
credible threats of serious adverse health consequences or death to 
humans or animals. Specific covered entities are those that 
manufacture, process, pack, transport, distribute, receive, hold, or 
import food. Farms and restaurants are excluded. The Secretary is 
directed to take into account the size of a business in promulgating 
these regulations. Section 306 of the Act also added section 414(a) and 
amended section 704(a) of FFDCA to permit FDA to inspect these records 
and other information if the Secretary has a reasonable belief that an 
article of food is adulterated and presents a threat of serious adverse 
health consequences or death to humans or animals.


Statement of Need:


The events of September 11, 2001, highlighted the need to enhance the 
security of the U.S. food supply. Congress responded by passing the 
Public Health Security and Bioterrorism Preparedness and Response Act 
of 2002 (the Bioterrorism Act), which was signed into law on June 12, 
2002. The regulations will implement section 306 of the Bioterrorism 
Act.


Summary of Legal Basis:


Section 306 of the Bioterrorism Act amended the FFDCA by adding section 
414(b), which authorizes the Secretary to establish by regulation 
requirements for the creation and maintenance of records. That section 
of the Bioterrorism Act also added section 414(a) and amended section 
704(a) of the FFDCA to permit FDA to inspect records and other 
information under certain circumstances. In addition, section 306 of 
the Bioterrorism Act also amends section 301 of the Federal Food, Drug, 
and Cosmetic Act by making the failure to establish or maintain any 
record required by the new regulations, or refusal to permit access to 
those records or other information as required by the new regulations, 
a prohibited act.

[[Page 72731]]

Alternatives:


None.


Anticipated Cost and Benefits:


The records provisions will be classified as significant under 
Executive Order 12866 (having an annual effect on the economy of over 
$100 million). The recordkeeping provisions would impose a substantial 
cost on industry. A first estimate is that the proposed provisions will 
cost the food industry approximately $235 million in the first year, 
approximately $510 million in the second year, and approximately $220 
million every year there after.


The provisions will improve substantially FDA's ability to respond to 
outbreaks from deliberate and accidental contamination of food. FDA 
will use data collected by the Center for Disease Control and 
Prevention (CDC) and FDA on past outbreaks to estimate the benefit of 
improved documentation in standard tracing investigations. Of the 1,344 
food-borne illness outbreaks CDC identified in 1999, only 368 (27 
percent) had a confirmed etiology. A host of factors contribute to the 
inability to identify the cause of an outbreak, but many investigations 
are hampered by the lack of adequate records identifying the chain of 
custody of foods. While it is not possible to directly estimate the 
benefits of averting a terrorist attack, as we do not know what form an 
attack might take or the probability of an attack occurring, FDA uses 
data collected by the agency on past outbreaks to estimate the benefit 
of the recordkeeping provisions on standard traceback investigations. 
Specifically, we estimate the number of illnesses averted from faster 
tracebacks and higher traceback completion rates that will result from 
improved recordkeeping practices.


Risks:


Regulations implementing legislation to protect the health of citizens 
against bioterrorism would advance the development, organization, and 
enhancement of public health prevention systems and tools. The 
magnitude of the risks addressed by such systems and tools is at least 
as great as the other risk reduction efforts within HHS' jurisdiction. 
These regulations will improve the ability to address credible threats 
of serious adverse health consequences or death to humans or animals.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            68 FR 25188                                    05/09/03
NPRM Comment Period End                                        07/08/03
Final Action                                                   12/00/04
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


URL For More Information:
www.fda.gov/oc/bioterrorism/bioact.html
URL For Public Comments:
www.fda.gov/ohrms/dockets/02n0277/02n0277.htm
Agency Contact:
Nega Beru
Supervisory Chemist, Office of Plant, Dairy Foods and Beverages
Department of Health and Human Services
Food and Drug Administration
HFS-305
Center for Food Safety and Applied Nutrition
5100 Paint Branch Parkway
College Park, MD 20740
Phone: 301 436-1400
Fax: 301 436-2651
Email: [email protected]
RIN: 0910-AC39
_______________________________________________________________________

HHS--FDA



55. REGISTRATION OF FOOD AND ANIMAL FEED FACILITIES
Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


This action may affect the private sector under PL 104-4.


Legal Authority:


PL 107-188, sec 305


CFR Citation:


21 CFR 1


Legal Deadline:


Final, Statutory, December 12, 2003.


The Public Health Security and Bioterrorism Preparedness and Response 
Act of 2002, section 305, directs the Secretary, through FDA, to issue 
a final regulation establishing registration requirements by December 
12, 2003. The statute is self-implementing on this date if FDA does not 
issue a final regulation that is effective by December 12, 2003.


Abstract:


This rulemaking is one of a number of actions being taken to improve 
FDA's ability to respond to threats of bioterrorism and other foodborne 
illness emergencies. Section 415 of the Federal Food, Drug, and 
Cosmetic Act (FFDCA), which was added by section 305 of the Public 
Health Security and Bioterrorism Preparedness and Response Act of 2002 
(the Bioterrorism Act), directs the Secretary to require facilities 
engaged in manufacturing, processing, packing, or holding of food for 
consumption in the United States to be registered with the Secretary. 
Section 415 directs the Secretary to promulgate final regulations 
implementing the requirements by December 12, 2003. The owner, 
operator, or agent in charge of the facility must submit the 
registration. Foreign facilities must include the name of the United 
States agent for the facility. The registration must include the name 
and address of each facility at which, and all trade names under which, 
the registrant conducts business. If the Secretary determines it is 
necessary through guidance, the registration must include the general 
food category (as identified under 21 CFR 170.3) of foods manufactured, 
processed, packed, or held at the facility. The registrant is required 
to notify the Secretary of changes to the information contained in the 
registration in a timely manner. Under the interim final rule (IFR) 
published on October 10, 2003 (68 FR 58894), upon receipt of the 
completed registration form, FDA will notify the registrant of receipt 
of the registration and assign a unique registration number to the 
facility. Section 415 requires the Secretary to compile and maintain an 
up-to-date list of registered facilities. This list and any 
registration documents submitted to the Secretary are not subject to 
disclosure under the Freedom of Information Act. For purposes of 
section 415, ``facility'' includes any factory, warehouse, or 
establishment engaged in the manufacturing, processing, packing, or 
holding of food. Exempt from the registration requirement are farms, 
restaurants, other retail food establishments, nonprofit food 
establishments in which food is prepared for or served directly to the

[[Page 72732]]

consumer, and fishing vessels (except those engaged in processing as 
defined in 21 CFR 123.3(k)). Foreign facilities required to register 
include only those from which food is exported to the United States 
without further processing or packaging outside the United States. The 
Bioterrorism Act provides that if food from an unregistered foreign 
facility is offered for import into the United States, the food will be 
held at the port of entry or at a secure facility, until the foreign 
facility has registered. On April 14, 2004, FDA issued a notice 
reopening for 30 days, on a limited range of issues, the comment period 
on the IFR. FDA took this action consistent with its statement in the 
IFR that it would reopen the comment period for 30 days in order to 
ensure that those commenting on the IFR had the benefit of FDA's 
outreach and educational efforts and had experience with the systems, 
timeframes, and data elements of the registration system.


Statement of Need:


The events of September 11, 2001, highlighted the need to enhance the 
security of the U.S. food supply. Congress responded by passing the 
Public Health Security and Bioterrorism Preparedness and Response Act 
of 2002, which was signed into law on June 12, 2002. This regulation is 
required by the Bioterrorism Act and is needed to implement the new 
statutory provision.


Summary of Legal Basis:


Section 305 of the Public Health Security and Bioterrorism Preparedness 
and Response Act of 2002 (the Bioterrorism Act) amends the FFDCA by 
adding section 415, which directs the Secretary to establish by 
regulation requirements for the registration of food and animal feed 
facilities. Section 305 amends section 301 of the FFDCA by making the 
failure to register in accordance with section 415 a prohibited act. 
Section 305 also amends section 801 of the FFDCA by requiring that food 
from an unregistered foreign facility that is offered for import into 
the United States be held at the port of entry or at a secure facility 
until the foreign facility has registered.


Alternatives:


None, based on clear statutory directive to establish the regulation.


Anticipated Cost and Benefits:


Costs: Requiring registration for domestic and foreign facilities that 
manufacture, process, pack, or hold food will create costs for 
facilities to register and for FDA to set up and administer a database 
of firms. Industry costs are primarily a function of the number of 
firms affected and the amount of labor needed to register those 
facilities. Foreign facilities are required to hire U.S. agents. FDA 
estimates that 216,721 domestic establishments and 205,405 foreign 
establishments covered by the statute and IFR will bear a cost of 
approximately $23 million and $306 million, respectively, in the first 
year. Annual costs will include new registration updates and fees for 
United States agents. For domestic facilities annual costs will be $6.9 
million. For foreign facilities annual costs will be $228.8 million. 
FDA's costs will include labor hours, hardware, software, and mailing 
costs for creating and administering a database. The costs to the 
agency for setting up the database and registering the first year 
registrants are estimated to be $13.2 million. This includes four FDA 
FTEs, contractor development of the database, hardware, software, 
industry outreach, and a firewall. The costs for maintaining the 
database and adding new establishments are estimated to be $8 million 
in the second year. Total first year costs will be $342.2 million and 
second year costs will be $243.7 million. In the IFR, FDA requested 
comment on certain issues relating to the costs of the U.S. Agent 
requirement.


Benefits: These provisions will improve FDA's ability to respond to 
outbreaks from accidental and deliberate contamination of food and 
deter deliberate contamination. It is not possible to directly estimate 
the benefits of averting a terrorist attack, as FDA does not know the 
probability of an attack occurring or the reduction in risk resulting 
from registration. Instead, in order to estimate the benefits of 
averting foodborne emergencies, the IFR evaluates the costs of some 
severe foodborne illness outbreaks.


Risks:


Regulations implementing legislation to protect the health of citizens 
against bioterrorism will advance the development, organization, and 
enhancement of public health prevention systems and tools. The 
magnitude of the risks addressed by such systems and tools is at least 
as great as the other risk reduction efforts within HHS' jurisdiction. 
This will improve the ability to address credible bioterrorist threats 
to food for humans or animals, and other food-related public health 
emergencies.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            68 FR 5377                                     02/03/03
Interim Final Ru68 FR 58894                                    10/10/03
Interim Final Ru69 FR 19766Period Reopened                     04/14/04
Interim Final Rule Comment Period Reopened End                 05/14/04
Final Rule                                                     06/00/05
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Catherine Copp
Special Assistance to the Associate Director, Office of Regulations and 
Policy
Department of Health and Human Services
Food and Drug Administration
Center for Food and Applied Nutrition
5100 Paint Branch Parkway
College Park, MD 20740
Phone: 301 436-1589
Fax: 301 436-2637
Email: [email protected]
RIN: 0910-AC40
_______________________________________________________________________

HHS--FDA



56. PRIOR NOTICE OF IMPORTED FOOD UNDER THE PUBLIC HEALTH SECURITY AND 
BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF 2002
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


PL 107-188, sec 307


CFR Citation:


21 CFR 1.276 et seq


Legal Deadline:


Final, Statutory, December 12, 2003.


The Public Health Security and Bioterrorism Preparedness and Response 
Act of 2002, section 307, directs the Secretary, through FDA, to issue 
final regulations establishing prior notice requirements for all 
imported food by December 12, 2003. If FDA fails

[[Page 72733]]

to issue final regulations by this date, the statute is self-executing 
on this date, and requires FDA to receive prior notice of not less than 
eight hours, nor more than five days until final regulations are 
issued.


Abstract:


This rulemaking is one of a number of actions being taken to improve 
FDA's ability to respond to threats of bioterrorism. Section 801(m) of 
the Federal Food, Drug, and Cosmetic Act (FFDCA), which was added by 
section 307 of the Public Health Security and Bioterrorism Preparedness 
and Response Act of 2002, authorizes the Secretary, through FDA, to 
promulgate final regulations by December 12, 2003. Section 801(m) 
requires notification to FDA prior to the entry of imported food. The 
required prior notice would provide the identity of the article of 
food; the manufacturer; the shipper; the grower, if known at the time 
of notification; the originating country; the shipping country; and the 
anticipated port of entry. The regulation identifies the parties 
responsible for providing the notice and explains the information that 
the prior notice is required to contain, the method of submission of 
the notice, and the minimum and maximum period of advance notice 
required. Section 307 also states that if FDA does not receive prior 
notice or receives inadequate prior notice, the imported food shall be 
refused admission and held at the port of entry until proper notice is 
provided.


Statement of Need:


The events of September 11, 2001, highlighted the need to enhance the 
security of the U.S. food supply. Congress responded by passing the 
Public Health Security and Bioterrorism Preparedness and Response Act 
of 2002 (the Bioterrorism Act), which was signed into law on June 12, 
2002. The regulations implement section 307 of the Bioterrorism Act.


Summary of Legal Basis:


Section 307 of the Bioterrorism Act amended the FFDCA by adding section 
801(m), which authorizes the Secretary through FDA to establish by 
regulation requirements for the notification to FDA prior to the entry 
of imported food. In addition, section 307 of the Bioterrorism Act also 
amends section 301 of the FFDCA by making the offering of a food for 
import or the importing of a food without prior notification, as 
required by the new regulations, a prohibited act.


Alternatives:


None, based on clear statutory directive to establish regulations.


Anticipated Cost and Benefits:


The prior notification provision is an economically significant 
regulatory action. For the calendar year 2002, there were approximately 
5.2 million human and animal food line items imported into U.S. 
commerce by airplane, train, vessel, and truck.


This final rule will require that FDA be notified prior to the arrival 
of the food. This rule may cause changes in current business practices 
for some importers, most likely those persons importing fresh produce 
and seafood. Costs will include the costs of preparing the prior 
notice, and the costs associated with delayed entry of fresh produce 
and seafood.


FDA costs will include the labor hours, hardware, and software costs to 
develop a stand-alone technology system to handle prior notice entries.


Having prior notice of imported food will help deter deliberate and 
accidental contamination of food shipments. Knowledge of when, where, 
and how imported food will enter the United States will help mitigate 
the effects of any potential food contamination issues.


It is not possible to directly estimate the benefits of averting a 
terrorist attack, as we do not know what form an attack might take or 
the probability of an attack occurring. However, we can look at some 
outbreaks attributed to imported foods to estimate the benefits of 
having prior notice.


Risks:


Regulations implementing legislation to protect the health of citizens 
against bioterrorism and other public health threats would advance the 
development, organization and enhancement of public health prevention 
systems and tools. The magnitude of the risks addressed by such systems 
and tools is at least as great as the other risk reduction efforts 
within HHS' jurisdiction. These regulations will improve the FDA's 
ability to address bioterrorism events and public-health threats 
associated with imported food.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            68 FR 5428                                     02/03/03
Interim Final Ru68 FR 58974                                    10/10/03
Interim Final Ru69 FR 19763Period Reopened                     04/14/04
Interim Final Rule Comment Period Reopened End                 07/13/04
Final Rule                                                     06/00/05
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Federal


Agency Contact:
Mary Ayling
Lead, Inspection and Compliance Team, Food Safety Staff
Department of Health and Human Services
Food and Drug Administration
HFS-32
Center for Food Safety and Applied Nutrition
5100 Paint Branch Parkway
College Park, MD 20740
Phone: 301 436-2131
Fax: 301 436-2605
Email: [email protected]
RIN: 0910-AC41
_______________________________________________________________________

HHS--FDA



57. USE OF OZONE-DEPLETING SUBSTANCES: REMOVAL OF ESSENTIAL USE 
DESIGNATION; ALBUTEROL
Priority:


Economically Significant. Major status under 5 USC 801 is undetermined.


Unfunded Mandates:


Undetermined


Legal Authority:


15 USC 402; 15 USC 409; 21 USC 321; 21 USC 331; 21 USC 335; 21 USC 342; 
21 USC 343; 21 USC 346a; 21 USC 348; 21 USC 351; 21 USC 352; 21 USC 
355; 21 USC 360b; 21 USC 361; 21 USC 362; 21 USC 371; 21 USC 372; 21 
USC 374; 42 USC 7671 et seq


CFR Citation:


21 CFR 2.125


Legal Deadline:


None


Abstract:


Under the Clean Air Act, the Food and Drug Administration (FDA) within 
the U.S. Department of Health and Human Services, in consultation with 
the

[[Page 72734]]

Environmental Protection Agency, is required to determine whether an 
FDA-regulated product that releases an ozone-depleting substance (ODS) 
is essential. The two agencies have tentatively determined that the two 
currently marketed non-ODS metered-dose inhalers (MDIs) will be 
satisfactory alternatives to albuterol MDIs that contain ODS, and have 
proposed to remove the essential use designations for albuterol MDIs. 
If the essential use designation is removed, albuterol MDIs that 
contain an ODS could not be marketed after a suitable transition 
period. The proposed rule specifically asked for comments on which 
phase-out period length will best ensure a smooth transition and 
minimize any adverse affects on the public health.


Statement of Need:


Chlorofluorocarbons (CFCs) are organic compounds that contain carbon, 
chlorine, and fluorine atoms. CFCs were first used commercially in the 
early 1930's and were later found to be useful as propellants in self-
pressurized aerosol products, such as MDIs. CFCs are very stable in the 
troposphere--the lowest part of the atmosphere. They move to the 
stratosphere, a region that begins about 10-16 kilometers (km) (6-10 
miles) above Earth's surface and extends up to about 50 km (31 miles) 
altitude. Within the stratosphere there is a zone about 15-40 km (10-25 
miles) above the Earth's surfaces in which ozone is relatively highly 
concentrated. The zone in the stratosphere is generally called the 
ozone layer. Once in the stratosphere, CFCs are broken down by strong 
ultraviolet light, where they release chlorine atoms that then deplete 
stratospheric ozone. Depletion of stratospheric ozone by CFCs and other 
ODS will lead to higher UVB levels, which in turn will cause increased 
skin cancers and cataracts and potential damage to some marine 
organisms, plants, and plastics.


The link between CFCs and the depletion of stratospheric ozone was 
discovered in the mid-1970's. Since 1978, the U.S. government has 
pursued a consistent policy of limiting the production and use of ODS, 
including CFCs.


Summary of Legal Basis:


The Clean Air Act and EPA's implementing regulations contain general 
prohibitions on the use and manufacture of ODS, such as CFCs. 
Exceptions to these bans are provided for specific medical products 
that FDA, in consultation with EPA, has found to be essential. FDA's 
essential use determinations have been contained in 21 CFR section 
2.125.


FDA published a new 21 CFR section 2.125 in the Federal Register on 
July 24, 2002 (67 FR 48370), (corrected in the Federal Registers of 
July 30, 2002 (67 FR 49396), and September 17, 2002 (67 FR 58678)). 
Section 2.125 provides criteria for determining when a use is essential 
and when a use is no longer essential. The procedures to determine when 
a use is no longer essential were implemented to better carry out 
responsibilities under both the Clean Air Act and the Montreal Protocol 
on Substances that Deplete the Ozone Layer, (September 16, 1987, S. 
Treaty Doc. No. 10, 100th Cong., 1st sess., 26 I.L.M. 1541 (1987)).


Fran Du Melle, Executive Vice President of the American Lung 
Association, submitted a citizen petition on behalf of the U.S. 
Stakeholders Group on MDI Transition on January 29, 2003 (Docket No. 
03P-0029/CP1). The petition requested that FDA initiate rulemaking to 
remove the essential use designation of albuterol MDIs. After 
evaluating the petition, comments submitted in response to the 
petition, and other information, FDA has tentatively determined that 
albuterol MDIs meet the criteria in section 2.125, and proposed a rule 
to remove other essential-use designations.


Alternatives:


In the proposed rule, FDA specifically requested comments on the best 
effective date for any final rule to remove the essential use status of 
albuterol MDIs. FDA is considering which dates will allow manufacturers 
to obtain the capacity to produce adequate numbers of non-ODS albuterol 
MDIs. FDA is also considering which dates might minimize any financial 
burden on patients who would have to switch to non-ODS albuterol MDIs.


Anticipated Cost and Benefits:


The expected benefit from this rulemaking, as part of an overall policy 
to eliminate production and use of ODSs, is the preservation of the 
Earth's stratospheric ozone.


Currently there are generic versions of ODS albuterol MDIs, while there 
are no generic non-ODS albuterol MDIs. This rulemaking could force 
patients to switch from lower-priced generic versions of ODS albuterol 
MDIs to higher-priced non-ODS albuterol MDIs.


Risks:


FDA is concerned about the possibility that some patients might stop 
using needed drugs because the prices of non-ODS albuterol MDIs might 
be higher than those of ODS albuterol MDIs.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            69 FR 33602                                    06/16/04
NPRM Comment Period End                                        08/16/04
Final Action                                                   03/00/05
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Agency Contact:
Wayne H. Mitchell
Regulatory Counsel, Office of Regulatory Policy
Department of Health and Human Services
Food and Drug Administration
Suite 3037 (HFD-7)
Center for Drug Evaluation and Research
5515 Security Lane
Suite 1101 (HFD-7)
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]
RIN: 0910-AF18
_______________________________________________________________________

HHS--FDA



58.  USE OF MATERIALS DERIVED FROM CATTLE IN HUMAN FOOD AND 
COSMETICS
Priority:


Other Significant


Legal Authority:


21 USC 342; 21 USC 361; 21 USC 371


CFR Citation:


21 CFR 189.5; 21 CFR 700.27


Legal Deadline:


None


Abstract:


On July 14, 2004, FDA issued an interim final rule, effective 
immediately, to prohibit the use of certain cattle material, to address 
the potential risk of bovine spongiform encephalopathy (BSE), in human 
food,

[[Page 72735]]

including dietary supplements, and cosmetics. Prohibited cattle 
materials include specified risk materials, small intestine of all 
cattle, material from nonambulatory disabled cattle, material from 
cattle not inspected and passed for human consumption, and mechanically 
separated (MS) (Beef). Specified risk materials are the brain, skull, 
eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the 
vertebrae of the tail, the transverse processes of the thoracic and 
lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia 
of cattle 30 months and older; and the tonsils and distal ileum of the 
small intestine of all cattle. Prohibited cattle materials do not 
include tallow that contains no more than 0.15 percent hexane-insoluble 
impurities and tallow derivatives. This action minimizes human exposure 
to materials that scientific studies have demonstrated are highly 
likely to contain the BSE agent in cattle infected with the disease. 
Scientists believe that the human disease variant Creutzfeldt-Jakob 
disease (vCJD) is likely caused by the consumption of products 
contaminated with the agent that causes BSE. After reviewing comments 
received to the interim final rule, FDA will finalize the prohibitions 
on certain cattle material.


Statement of Need:


FDA is taking this action in response to the finding of an adult cow, 
imported from Canada, that tested positive for BSE in the State of 
Washington. This action will minimize human exposure to materials that 
scientific studies have demonstrated are highly likely to contain the 
BSE agent in cattle infected with the disease. Scientists believe that 
the human disease variant Creutzfeldt-Jakob disease (vCJD) is likely 
caused by the consumption of products contaminated with the agent that 
causes BSE.


Summary of Legal Basis:


FDA's legal basis for the IFR derived from the adulteration provisions 
in sections 402(a)(2)(C), 402(a)(3), 402(a)(4), 402(a)(5), 601(c), and 
under section 701(a) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. sections 342(a)(2)(C), 342(a)(3), 342(a)(4), 342(a)(5), 361(c), 
and 371(a)). Under section 402(a)(3) of the Act, a food is deemed 
adulterated ``if it consists in whole or in part of any filthy, putrid, 
or decomposed substance, or if it is otherwise unfit for food.'' 
Because of the discovery of a BSE positive cow in the United States and 
the possibility of disease transmission to humans from exposure to 
material from infected cattle, BSE risk materials are unfit for food. 
Furthermore, some cattle are not inspected and passed because they have 
died before slaughter. Material from these cattle is adulterated under 
section 402(a)(5). The failure to ensure that food or cosmetics are 
prepared, packed, or held under conditions in which BSE risk materials 
do not contaminate the food or cosmetics constitutes an insanitary 
condition whereby the food or cosmetics may have been rendered 
injurious to health and thus renders the food or cosmetics adulterated 
under section 402(a)(4) or 601(c).


We are also relying on the food additive provision in section 
402(a)(2)(C). Because neither a food additive regulation nor an 
exemption is an effect for BSE risk materials intended for use in human 
food, such materials, with the exception of dietary ingredients in 
dietary supplements, are adulterated under section 402(a)(2)(C) of the 
act and their presence in food renders the food adulterated. Finally, 
requiring measures to prevent food and cosmetics from being adulterated 
allows for efficient enforcement of the act under section 701(a). Once 
material is removed from cattle, we may not be able to obtain the 
information necessary to determine whether it is BSE risk material. 
Therefore, the records access requirement is also necessary for the 
efficient enforcement of this rule.


Alternatives:


There were several alternatives considered to the interim final rule. 
These same alternatives, plus any new ones presented in comments, will 
be considered for the final.


 No new regulation.


 Prohibit the use of prohibited cattle materials in human food 
and cosmetics and require access to existing records relevant to 
determine compliance.


 Prohibit the use of prohibited cattle materials in human food 
and cosmetics and require establishment, maintenance, and access to 
records demonstrating that prohibited cattle materials are not used in 
human food and cosmetics.


Anticipated Cost and Benefits:


We expect the social cost of the final rule, which we approximate by 
multiplying the difference in ingredient prices by the preregulation 
quantity of ingredients, will be borne by producers and consumers of 
affected products. If demand is inelastic compared with supply, 
consumers will bear most of the social cost. If supply is inelastic 
compared with demand, producers will bear most of the social cost. The 
ready availability of alternatives for the prohibited ingredients, and 
the small number of products currently using them, implies that the 
social costs of this rule will likely be small for foods. The social 
costs for cosmetics will be greater. We estimate that the cost of 
ingredient switching for cosmetics will range from a lower bound of $0 
to an upper bound of $18 million. The benefit of the final rule is that 
its requirements will-by reducing exposure to potentially infective 
materials-provide a safeguard against a case of vCJD occurring in 
humans if cattle infected with BSE enter the human food or cosmetic 
supply.


Risks:


The benefits of the final rule will be the value of the public health 
benefits. The public health benefit is the reduction in the risk of the 
human illness associated with consumption of the agent that causes BSE. 
The Harvard-Tuskegee risk assessment has stated that a ban on specified 
risk materials, including cattle brains, spinal cord and vertebral 
column, from inclusion in human and animal food would reduce the very 
few potential BSE cases in cattle by a further 88 percent and potential 
human exposure to infectivity in meat and meat products by a further 95 
percent.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Interim Final Ru69 FR 42256                                    07/14/04
Interim Final Rule Comment Period End                          10/12/04
Final Action                                                   03/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None

[[Page 72736]]

Agency Contact:
Rebecca Buckner
Consumer Safety Officer
Department of Health and Human Services
Food and Drug Administration
HFS-306
Center for Food Safety and Applied Nutrition
5100 Paint Branch Parkway
HFS-366
College Park, MD 20740
Phone: 301 436-1486
Fax: 301 436-2632
Email: [email protected]
RIN: 0910-AF47
_______________________________________________________________________

HHS--FDA



59.  RECORDKEEPING REQUIREMENTS FOR HUMAN FOOD AND COSMETICS 
MANUFACTURED FROM, PROCESSED WITH, OR OTHERWISE CONTAINING MATERIAL 
FROM CATTLE
Priority:


Other Significant


Legal Authority:


21 USC 342; 21 USC 361; 21 USC 371; 21 USC 381


CFR Citation:


21 CFR 189.5; 21 CFR 700.27


Legal Deadline:


None


Abstract:


On July 14, 2004, FDA proposed to require that manufacturers and 
processors of human food and cosmetics that are manufactured from, 
processed with, or otherwise contain, material from cattle must 
establish and maintain records sufficient to demonstrate the food or 
cosmetic is not manufactured from, processed with, or does not 
otherwise contain, prohibited cattle materials. This is a companion 
rulemaking to FDA's interim final rule entitled ``Use of Materials 
Derived From Cattle in Human Food and Cosmetics.`` FDA intends to 
finalize this proposal after reviewing any comments received.


Statement of Need:


FDA proposed recordkeeping requirements because records documenting the 
absence of prohibited cattle materials are needed by manufacturers and 
processors of human food and cosmetics that contain cattle material to 
ensure that these products do not contain prohibited cattle materials. 
Prohibited cattle materials are materials that scientific studies have 
demonstrated are highly likely to contain the BSE agent in cattle 
infected with the disease. Scientists believe that the human disease 
variant Creutzfeldt-Jakob disease (vCJD) is likely caused by the 
consumption of products contaminated with the agent that causes BSE.


Summary of Legal Basis:


Because the rule is a companion rulemaking to the interim final rule 
prohibiting the use of certain cattle material in human food and 
cosmetics, we issued the proposed rule under the authorities cited in 
the interim final rule (21 U.S.C. sections 342(a)(2)(C), 342(a)(3), 
342(a)(4), 342(a)(5), 361(c), and 371(a)) as well as sections 801(a) 
and 701(b) of the Federal Food, Drug, and Cosmetic Act (the Act). 
Without records documenting the absence of BSE risk materials in source 
materials, manufacturers and processors of human food and cosmetics 
cannot know whether they are adulterating their products by including 
BSE risk materials in their products. Therefore, a failure of 
manufacturers and processors to establish and maintain such records 
results in human food and cosmetics being prepared under unsanitary 
conditions whereby they may have been rendered injurious to health. 
Furthermore, without adequate records, FDA cannot know whether 
manufacturers and processors of human food and cosmetics have complied 
with the prohibitions against use of BSE risk materials. Therefore, the 
recordkeeping requirements are necessary for the efficient enforcement 
of the interim final rule.


We are also issuing the provisions of this proposed rule related to 
records regarding imported human food and cosmetics under sections 
801(a) and 701(b) of the Act. Section 801(a) (21 U.S.C. 381(a)) 
provides for refusal of admission into the United States of human food 
and cosmetics that appear to be adulterated. Section 701(b) (21 U.S.C. 
371(b)) authorizes the Secretaries of Treasury and Health and Human 
Services to jointly prescribe regulations for the efficient enforcement 
of section 801. This proposed rule sets out requirements for imported 
human food and cosmetics to ensure that only products that fully comply 
with the requirements of the interim final rule are admitted into the 
United States.


Alternatives:


Alternatives were not specifically considered in the proposed rule 
because it was a companion rulemaking to the interim final rule 
prohibiting the use of certain cattle material in human food and 
cosmetics. Recordkeeping alternatives were considered in the interim 
final rule. Those same alternatives, plus any new ones presented in 
comments, will be considered for the final rule.


Anticipated Cost and Benefits:


If the proposal is finalized, we expect that the costs will be to setup 
and then to maintain a recordkeeping system to document all cattle-
derived ingredients, except tallow derivatives, used in FDA-regulated 
food and cosmetics. The setup costs are about $1 million, and the 
annual costs of maintaining the recordkeeping system are about 
$200,000. The benefit of the rule is that its requirements will--by 
requiring records that the provisions of the interim final rule have 
been followed--provide an additional safeguard against a case of vCJD 
occurring in humans.


Risks:


The benefits of finalizing the proposed rule are derived from the 
benefits of the interim final rule, which are the value of the public 
health benefits. The public health benefit is the reduction in the risk 
of the human illness associated with consumption of the agent that 
causes BSE. The Harvard-Tuskegee risk assessment has stated that a ban 
on specified risk materials, including cattle brains, spinal cord and 
vertebral column, from inclusion in human and animal food would reduce 
the very few potential BSE cases in cattle by a further 88 percent and 
potential human exposure to infectivity in meat and meat products by a 
further 95 percent.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            69 FR 42275                                    07/14/04
NPRM Comment Period End                                        08/13/04
Final Action                                                   03/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


None

[[Page 72737]]

Agency Contact:
Rebecca Buckner
Consumer Safety Officer
Department of Health and Human Services
Food and Drug Administration
HFS-306
Center for Food Safety and Applied Nutrition
5100 Paint Branch Parkway
HFS-366
College Park, MD 20740
Phone: 301 436-1486
Fax: 301 436-2632
Email: [email protected]
RIN: 0910-AF48
_______________________________________________________________________

HHS--Centers for Medicare & Medicaid Services (CMS)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




60. END STAGE RENAL DISEASE (ESRD) CONDITIONS FOR COVERAGE (CMS-3818-P) 
(SECTION 610 REVIEW)
Priority:


Other Significant


Legal Authority:


42 USC 1395rr


CFR Citation:


42 CFR 400; 42 CFR 405; 42 CFR 406; 42 CFR 409; 42 CFR 410; 42 CFR 412; 
42 CFR 488; 42 CFR 489; 42 CFR 494; 42 CFR 413; 42 CFR 414


Legal Deadline:


None


Abstract:


This proposed rule would revise the requirements that end stage renal 
disease (ESRD) facilities must meet to be certified under the Medicare 
program.


Statement of Need:


This proposed rule is a complete overhaul of the current ESRD 
conditions for coverage to reduce unnecessary process and procedural 
requirements and focus on the patient and the results and quality of 
the care furnished to the patient. The proposed conditions for ESRD 
facilities would include, among other things, new infection control 
guidelines; updated water quality standards; new fire safety standards; 
as well as patient assessment, care planning, quality improvement, and 
electronic data reporting provisions that reflect the current advances 
in dialysis technology and standard care practices. The ESRD conditions 
were last published in their entirety in 1976.


Summary of Legal Basis:


Section 1881 (42 U.S.C. 1395rr) of the Social Security Act (the Act) 
authorizes benefits for individuals who have been determined to have 
end stage renal disease as provided in section 226 (A). Section 1881(b) 
of the Act authorizes payments on behalf of such individuals to 
providers of services and renal dialysis facilities ``which meet 
requirements as the Secretary shall by regulation prescribe.'' ESRD 
conditions for coverage may be revised as needed under the Secretary's 
rulemaking authority in section 1881.


Alternatives:


Retain the current conditions. CMS has undertaken various quality 
improvement initiatives, e.g., the Dialysis Facility Compare Web site 
and the CMS Clinical Performance Measures Project that have improved 
beneficiaries' quality of care. These initiatives, however, lack the 
potential impact of an overall regulatory change.


Anticipated Cost and Benefits:


We anticipate a minimal cost for each dialysis facility in the initial 
year of implementation and in subsequent years. These costs are thought 
to be a small percent of dialysis facilities' expenses.


Risks:


Failure to update would result in outdated ESRD conditions for coverage 
that are over 26 years old and do not reflect current medical practices 
or scientific advances in the field.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           11/00/04
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Robert Miller
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
S3-02-01
Office of Clinical Standards and Quality
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-6797

Teresa Casey
Health Insurance Specalist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
S3-05-04
Office of Clinical Standards and Quality
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-7215
RIN: 0938-AG82
_______________________________________________________________________

HHS--CMS



61. HOSPITAL CONDITIONS OF PARTICIPATION: REQUIREMENTS FOR APPROVAL AND 
REAPPROVAL OF TRANSPLANT CENTERS TO PERFORM ORGAN TRANSPLANTS (CMS-
3835-P)
Priority:


Other Significant


Legal Authority:


42 USC 1302; 42 USC 1395hh


CFR Citation:


42 CFR 482


Legal Deadline:


None


Abstract:


This proposed rule would establish conditions of participation for 
Medicare-covered transplants.


Statement of Need:


CMS is proposing new requirements for transplant centers to address 
several issues. First, although currently there are initial 
requirements hospitals must meet to become Medicare-approved to perform 
transplants, there are no requirements for reapproval. Thus, once a 
transplant center has received initial approval, CMS has no mechanism 
to remove the center's approval if its performance declines. Second, 
current outcome measures for initial approval are not risk adjusted and 
do not reflect the significant improvements in patient survival that 
have occurred in the years since the Medicare requirements were

[[Page 72738]]

put into place. Finally, current requirements for Medicare approval are 
difficult for transplant centers to locate and use, as they have been 
published in a variety of different documents, including the Federal 
Register, the Coverage Issues Manual, and Medicare Coverage Policy 
Decision Memoranda. Therefore, it is intended that the transplant 
requirements: (1) ensure that transplants are performed safely and 
effectively by establishing requirements for approval and re-approval 
and a process for oversight and enforcement activities; (2) establish 
risk-adjusted outcome measures that reflect improvements in patient and 
graft survival and ongoing changes in transplantation technology; and, 
(3) codify requirements for all transplant center types in one 
regulation.


Summary of Legal Basis:


The Medicare statute contains specific authority for prescribing the 
health and safety requirements for facilities to furnish ESRD care to 
beneficiaries, including renal transplant centers, under section 
1181(b)(1) of the Social Security Act. Section 1102 of the Act 
authorizes the Secretary to publish rules and regulations ``necessary 
for the efficient administration of the functions with which the 
Secretary is charged under the Act.'' Section 1871 (a) of the Act 
authorizes the Secretary to ``prescribe such regulations as may be 
necessary to carry out the administration of the insurance programs 
under this title.``


Alternatives:


CMS has considered various alternatives in developing outcome and 
process performance measures for transplant centers. CMS will propose 
requirements for initial and reapproval and will solicit public 
comments to identify additional alternatives.


Anticipated Cost and Benefits:


CMS estimates the economic impact of this rule to be $300,148 annually. 
While 867 transplant centers may be affected by the requirements in 
this proposed rule to a greater or lesser degree, the majority of the 
centers most likely have already put into practice the majority of the 
proposed process requirements. For the most part, the proposed 
requirements merely reflect advances in transplantation technology, as 
well as standard care practices. Furthermore, although the proposed 
rule would require a large amount of data to be submitted to the Organ 
Procurement and Transplantation Network (OPTN), transplant centers 
already submit these data to the OPTN.


In 2002, 12,795 donors (deceased and living) were recovered in the U.S. 
and 24,851 transplants (deceased and living donors) were performed; yet 
80,792 patients were waiting for a transplant at the end of 2002. Given 
the scarcity of donated organs compared to the number of patients on 
waiting lists and the critical need to use limited resources 
efficiently, the proposed requirements for transplant centers would 
establish quality and procedural standards that ensure transplants are 
performed in a safe and effective manner both to protect transplant 
recipients and living donors and to improve graft survival, thus 
reducing the need for costly retransplantation following a failed 
original transplant.


Organ donation and transplantation is a priority for the Secretary as 
evidenced by the Secretary's Donation Initiative (Initiative); launch 
of the Initiative was one of the Secretary's first actions. The 
proposed rule will include requirements to guard against medical errors 
that endanger living donors and transplant recipients, including the 
transplantation of organs of the wrong blood type.


Risks:


Failure to publish the proposed requirements would result in the 
continued Medicare approval of transplant centers that may not perform 
organ transplants safely and effectively with the best possible 
outcomes for Medicare beneficiaries and other patients.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           11/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses, Organizations


Government Levels Affected:


None


Agency Contact:
Eva Fung
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
S3-06-6
Office of Clinical Standards and Quality
S3-06-06
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-7539

Aucha Prachanronarong
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Office of Clinical Standards and Quality
S3-02-01
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-9614
RIN: 0938-AH17
_______________________________________________________________________

HHS--CMS



62. HOSPICE CARE--CONDITIONS OF PARTICIPATION (CMS-3844-P)
Priority:


Other Significant


Legal Authority:


42 USC 1302; 42 USC 1395hh


CFR Citation:


42 CFR 418


Legal Deadline:


None


Abstract:


This proposed rule is a regulatory reform initiative that would revise 
existing conditions of participation that hospices must meet to 
participate in the Medicare and Medicaid programs. The proposed 
requirements focus on the actual care delivered to patients and 
patients' families by hospices and the results of that care, reflect an 
interdisciplinary view of patient care, allow hospices greater 
flexibility in meeting quality standards, and eliminate unnecessary 
procedural requirements.


Statement of Need:


This rule proposes to completely revise and reorganize the existing 
Conditions of Participation (CoPs) for Medicare participating hospice 
providers published in 1983. The proposed rule is a regulatory reform 
initiative that would revise the existing CoPs that hospices must meet 
to participate in

[[Page 72739]]

the Medicare and Medicaid programs. The proposed requirements focus on 
the care delivered to patients and patients' families by hospices and 
the outcomes of that care. The proposed requirements continue to 
reflect an interdisciplinary view of patient care and allow hospices 
flexibility in meeting quality standards. These changes are an integral 
part of the Administration's efforts to achieve broad-based 
improvements in the quality of health care furnished through the 
Medicare and Medicaid programs. This proposed rule codifies hospice 
requirements in the Balanced Budget Act of 1997 and the Medicare 
Modernization Act of 2003, sections 408 and 946.


Summary of Legal Basis:


Section 1861(dd) of the Social Security Act (the Act) provides the 
statutory qualifications and requirements that a hospice must meet to 
receive payment for hospice care given to Medicare beneficiaries who 
elect the hospice benefit under the Medicare and Medicaid programs. 
This section gives the Secretary broad authority to establish standards 
for hospices. Under this authority, the Secretary established CoPs for 
hospices at 42 CFR 418, et seq.


In addition, section 1102 of the Act gives the Secretary the authority 
to make and publish such rules and regulations as may be necessary to 
the efficient administration of the functions with which he is charged 
under the Act. This section of the Act gives the Secretary broad 
authority to establish requirements for hospices that are necessary for 
the efficient administration of the Medicare program.


Alternatives:


Rely on the current CoPs: This is not a reasonable option because the 
current CoPs are not patient-focused but rather problem-focused, an 
approach that has inherent limits. Trying to ensure quality through the 
enforcement of prescriptive health and safety standards, rather than 
trying to improve quality of care for all patients, adversely affects 
agency improvement efforts and does not stimulate broad-based quality 
of care initiatives. On the other hand, revising the current CoPs would 
take advantage of continuing advances in health care delivery.


Increase prescriptive requirements relative to patient rights, drugs 
and durable medical equipment, and personnel qualifications. CMS 
decided not to pursue this approach because the additional burden that 
would be placed on hospices would outweigh any potential benefits.


Exclude the revisions to the comprehensive assessment and 
interdisciplinary group requirements: Since these areas represent two 
of the most frequently cited deficiencies noted during hospice surveys 
and have a great impact on patient care, CMS decided that these 
sections did, in fact, need to be strengthened.


Anticipated Cost and Benefits:


While we anticipate a minimal annual cost per hospice to comply with 
the requirements in this rule, we expect a positive reaction from all 
affected entities including beneficiaries, associations, and providers. 
This rule is highly anticipated by the hospice industry since the 
standards have not been updated since 1990.


Risks:


Overall, this rule is a ``good news rule'' for which we expect a 
positive reaction from all affected entities including beneficiaries, 
associations, providers, and Congress. Beneficiaries--we expect that 
beneficiaries will be pleased with the strong focus on patient's 
rights, patient education, and patient safety throughout the proposed 
rule. Associations--the National Hospice and Palliative Care 
Organization and the National Association for Home Care have been 
requesting the promulgation of new regulations for several years and 
has actively worked with us in sharing information. Hospice providers--
hospices may have mixed feelings about the proposed regulations. We are 
proposing to bring the regulations in line with current standards of 
practice and are proposing to substantially decrease provider burden in 
many areas of the proposed rule such as in nurse staffing and dietary 
counseling. However, we are also proposing to increase the focus on 
patient assessment, quality assessment, and performance improvement 
that may require an additional level of effort. We believe that the 
patient safety and quality care benefits should outweigh these 
concerns. In response to requests from hospice and nursing facility 
associations, we have clarified the relationship between hospices and 
nursing facilities through a proposed new condition. Nurse 
practitioners (NPs)--we are proposing to allow NPs to see, treat, and 
write orders for patients, as defined by the plan of care. Congress--we 
do not expect that these proposed regulations would be opposed in their 
overall approach to patient care.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           11/00/04
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


 Businesses, Organizations


Government Levels Affected:


None


Federalism:


 Undetermined


Agency Contact:
Mary Rossi Coajou
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Office of Clinical Standards and Quality
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-6051

Danielle Shearer
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Office of Clinical Standards and Quality
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-6617
RIN: 0938-AH27
_______________________________________________________________________

HHS--CMS



63. ORGAN PROCUREMENT ORGANIZATION CONDITIONS FOR COVERAGE (CMS-3064-P)
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


Not Yet Determined


CFR Citation:


Not Yet Determined


Legal Deadline:


Final, Statutory, January 1, 2002, Requires promulgation of new 
conditions.


Abstract:


This rule would establish conditions for coverage for organ procurement 
organizations (OPOs) to be certified by the Secretary to receive 
payment from

[[Page 72740]]

Medicare and Medicaid for organ procurement costs, and to be designated 
by the Secretary for a specific geographic service area. The Organ 
Procurement Organization Certification Act of 2000 requires CMS to 
increase the certification cycle for OPOs from 2 years to 4 years and 
to promulgate new performance standards for OPOs.


Statement of Need:


As required by the Organ Procurement Organization Certification Act of 
2000 and Section 219 of the Consolidated Appropriations Act, 2001, this 
proposed rule sets forth multiple new outcome and process performance 
measures for OPOs, as well as a new appeals process for OPOs to appeal 
a decertification based on substantive and procedural grounds.


Summary of Legal Basis:


Section 1138(b) of the Social Security Act (the Act) provides the 
statutory qualifications and requirements that an OPO must meet to 
receive payment for organ procurement costs associated with procuring 
organs for hospitals under the Medicare and Medicaid programs. This 
section gives the Secretary broad authority to establish performance-
related standards for OPOs. Under this authority, the Secretary 
established conditions for coverage for OPOs at 42 CFR 486.301, et seq. 
Section 1138(b) of the Act specifies that an OPO must be certified or 
re-certified by the Secretary as meeting the standards to be a 
qualified OPO as described in section 371(b) of the Public Health 
Service (PHS) Act. The PHS Act requirements were established by the 
National Organ Transplant Act of 1984 and include provisions for OPO 
board membership, staffing, agreements with hospitals, and membership 
in the OPTN. The Organ Procurement Organization Certification Act of 
2000 (42 U.S.C. section 273(b)(1)(D)) amended section 371(b) of the PHS 
Act to require CMS to promulgate multiple new outcome and process 
performance measures for OPOs and develop a new process for OPOs to 
appeal a decertification based on substantive and procedural grounds.


In addition, section 1102 of the Act gives the Secretary the authority 
to make and publish such rules and regulations as may be necessary to 
the efficient administration of the functions with which the Secretary 
is charged under the Act. This section of the Act gives the Secretary 
broad authority to establish requirements for OPOs that are necessary 
for the efficient administration of the Medicare program.


Alternatives:


CMS has considered various alternatives in developing outcome and 
process performance measures. CMS will propose measures based on donor 
potential and other related factors in OPO service areas and CMS will 
solicit public comments to identify additional alternatives.


Anticipated Cost and Benefits:


CMS believes the provisions contained in this proposed rule would have 
little or no economic impact on hospitals and would not have a 
substantial economic impact on a significant number of OPOs.


It is expected that improved OPO performance would result from the rule 
and would increase organ donation and transplantation, thereby 
decreasing deaths of patients waiting for organs. Increasing organ 
donation and transplantation is a priority for the Secretary as 
evidenced by the Secretary's Donation Initiative (Initiative); launch 
of the Initiative was one of the Secretary's first actions.


In addition, the proposed rule would include requirements to guard 
against medical errors that can lead to transplantation of organs of 
the wrong blood type or transmission of infectious disease to 
transplant recipients.


Risks:


Failure to publish the rule may decrease organ donation and 
transplantation, thereby increasing deaths of patients waiting for 
organs.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Interim Final Ru66 FR 67109                                    12/28/01
NPRM                                                           11/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Marcia Newton
Department of Health and Human Services
Centers for Medicare & Medicaid Services
S3-02-01
Office of Clinical Standards and Quality
7500 Security Boulevard
S3-05-18
Baltimore, MD 21244-1850
Phone: 410 786-5265
RIN: 0938-AK81
_______________________________________________________________________



HHS--CMS



64. USE OF RESTRAINT AND SECLUSION IN MEDICARE AND MEDICAID 
PARTICIPATING FACILITIES THAT PROVIDE INPATIENT OR RESIDENTIAL CARE 
(CMS-2130-P)
Priority:


Other Significant. Major status under 5 USC 801 is undetermined.


Legal Authority:


PL 106-554, (BIPA 2000 of the Children's Health Act)


CFR Citation:


42 CFR 101; 42 CFR 418; 42 CFR 482; 42 CFR 483; 42 CFR 485


Legal Deadline:


None


Abstract:


This proposed rule would implement provisions of the Children's Health 
Act of 2000 (CHA) related to the use of restraints or seclusion for 
individuals receiving services in health care facilities that receive 
Federal funding. The rule would establish common terminology and basic 
expectations for the use of restraints and seclusion for health care 
facilities that furnish inpatient or residential care and receive 
Medicare or Medicaid funding.


Statement of Need:


In recent years, media, Government, and consumer reports of deaths and 
injuries occurring due to the use of restraint or seclusion have 
heightened concern about these mechanisms as interventions. Concern 
about use is nothing new; however, the appropriate use of restraint and 
seclusion has been debated and regulated in various health care 
settings for many years. Researchers have examined the use of restraint 
and seclusion, related injuries and deaths, and potential alternatives 
to address safety and care concerns while posing less inherent risk to 
the

[[Page 72741]]

individual. Patient advocates have lobbied for reduced and more highly 
regulated use. Health care facilities and professionals have examined 
mechanisms for reduction, and some have implemented training programs 
to promote safe application and use. Reports of injuries and deaths, 
however, have brought concerns about care and safety to the forefront. 
The issue has gained national attention, with a call for regulation 
across health care settings.


Several highly publicized newspaper articles and Federal reports are 
the impetus for this regulation. The CHA established a significant 
collaboration of several important children's health bills. CMS has 
responsibility for part H, which established certain requirements 
related to the rights of residents of certain facilities receiving 
Federal funds. SAMHSA intends to publish a notice of proposed 
rulemaking to implement part I, which sets forth requirements related 
to the rights of residents of certain nonmedical, community-based 
facilities for children and youth. The CHA establishes for certain 
facilities common definitions, staff training standards, reporting 
requirements, and strict enforcement criteria.


Summary of Legal Basis:


The Children's Health Act of 2000 (Pub. L. 106-310), section 3207, part 
H.


Alternatives:


No other regulatory alternatives were considered. Nevertheless, current 
regulations exist, in some form, for hospitals and residential 
treatment facilities, while nursing homes and ICFs/MR use survey 
guidelines. The CHA's intent is to develop consistency in requirements 
across all Federally-funded patient or residential care facilities. The 
statutory language required that regulations be promulgated within one 
year of its enactment. This proposed rule is currently two years behind 
its mandated time of publication.


Anticipated Cost and Benefits:


The anticipated benefits include enhanced patient safety and better 
consumer protections. Increases in staff education and training are 
expected to lead to treatment alternatives and decreases in the use of 
restraint and seclusion as a means of intervention, which then leads to 
less traumatic experiences for both beneficiaries and staff. The 
regulation creates a change in facility practices and policies on the 
use of restraint or seclusion as a treatment mechanism. The regulation 
will create standard criteria for patient or residential care 
facilities that receive Federal funds, which will establish an 
industrywide effect on beneficiaries who are receiving services within 
these Federal facilities. The regulation creates consistent criteria 
for staff training, and defining and reporting on restraint or 
seclusion.


The anticipated cost is based on regulations that will affect more than 
32,350 Medicare and Medicaid funded facilities. At this time, however, 
the extent of potential facilities affected is unattainable until 
comments are received from other HHS agencies. It is estimated that the 
cost will be roughly $500 million per a year for Federal Medicaid, and 
$2.5 billion to $3 billion for all payers. The proposed rule will 
specifically solicit comments on actual staff training and reporting 
costs, and it is assumed this cost will decrease since the majority of 
facilities currently have training and reporting requirements.


Risks:


The risk in implementing the regulation -


1. Increase in cost for facilities in staff training; however, 
facilities that currently use restraint or seclusion as a form of 
intervention have some general staff training requirements. The CHA 
will only expand the content of this training.


2. Increase possibility of facilities having their Federal funding 
status placed in jeopardy due to noncompliance with regulations. 
Industry may raise concern that the CHA's enforcement aspect is too 
harsh. For nursing homes, argument may occur that the CHA's enforcement 
goes against the intent of the Congress and its OBRA '87 language to 
devise other alternative sanctions besides termination from the 
Medicare or Medicaid programs.


3. Concern from facilities that currently do not have any regulations 
governing the use of restraints or seclusion (for example, nursing 
homes, hospice inpatient facilities, critical access hospitals; however 
nursing homes have requirements in their survey guidance materials).


The risk in not implementing the regulation -


1. Continued unregulated use of restraint and seclusion in certain 
Federally funded facilities.


2. Continued under reporting of deaths as a result of restraint or 
seclusion, or deaths that occur within 24 hours after an individual has 
been restrained or in seclusion, or where it is reasonable to assume 
that the individual's death was caused by being placed in restraints or 
in seclusion.


3. Barrage of continued concerns from advocacy groups and Congress to 
publish this regulation, as well as requests from facilities for 
guidance.


4. Lack of protection for special needs populations, such as children, 
adolescents, persons with mental illness, developmental disabilities, 
or co-occurring mental retardation who are disproportionately affected 
by the usage of restraint or seclusion as a common form of 
intervention.


5. Lack of direction to organizations, advocacy groups, and more than 
32,350 facilities for developing common definition.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           04/00/05
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


 Businesses


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Agency Contact:
Carla McGregor
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Center for Medicaid and State Operations
7500 Security Boulevard
S2-09-23
Baltimore, MD 21244
Phone: 410 786-7089
RIN: 0938-AL26
_______________________________________________________________________



HHS--CMS



65.  REVISIONS TO THE OVERSIGHT AND VALIDATION PROGRAM FOR 
ACCREDITING ORGANIZATIONS APPROVED FOR DEEMING AUTHORITY (CMS-2255-P)
Priority:


Other Significant. Major under 5 USC 801.

[[Page 72742]]

Legal Authority:


Social Security Act, sec 1864; Social Security Act, sec 1865; Social 
Security Act, sec 1875


CFR Citation:


42 CFR 488.1 to 488.9


Legal Deadline:


None


Abstract:


This rule is in response to the recommendations in the GAO Report, 
``CMS Needs Additional Aurthority to Adequately Oversee Patient Safety 
in Hospitals'' (GAO-04-850). With resepct to the oversight and 
validation of hospital accreditation programs, a rate if disparity 
calculation is specified in Federal regulations at 42 CFR, section 
488.8. This rule proposes to consider additional alternative measures 
to assess the performance of the accreditation organizations.


Statement of Need:


In the Department's official response to the recommendations in the GAO 
Report dealing with accredited hospitals, (GAO-04-850, ``CMS Needs 
Additional Authority to Adequately Oversee Patient Safety in 
Hospitals''), the Administrator committed to proposing that this 
regulatory initiative be added to the Department's regulatory plan for 
fiscal year 2005. With respect to the oversight and validation of 
hospital accreditation programs, a rate of disparity calculation is 
specified in Federal regulations at 42 CFR section 488.8. The agency 
agreed that it is quite appropriate to reexamine the rule and to 
consider additional or alternative measures to assess the performance 
of the accreditation organizations. CMS has already begun to examine 
this issue as part of the agency's hospital quality improvement 
activities. CMS is working to refine existing measures and develop new 
ones. It will be necessary to undertake rulemaking to revise the 
formula for calculating the rate of disparity measure, as well as to 
validate the threshold for acceptable performance or reasonable 
assurance. The notice and comment procedures inherent in the rulemaking 
process will provide an appropriate forum for this discussion of this 
significant public policy and will allow all of the stakeholders to 
participate. It will also provide for exposure to new perspectives and 
may yield innovative approaches to these problems. In addition, CMS 
will explore regulatory strategies to address the long-standing JCAHO 
performance issues with respect to the Life Safety Code.


Summary of Legal Basis:


Sections 1864, 1865, and 1875 of the Social Security Act.


Alternatives:


None. There are no alternative authorities that would permit this 
regulation to be issued as an interim final rule or final rule.


Anticipated Cost and Benefits:


None. There are no alternative authorities that would permit this 
regulation to be issued as an interim final rule or final rule.


Risks:


Risks include higher expenditures for the survey and certification 
program in conducting validation surveys of accredited providers and in 
other improvements to the measures and analyses used to evaluate the 
performance of accrediting organizations for inclusion in the annual 
report to Congress. Unless these additional costs are addressed through 
the appropriation and budget processes, reallocation of existing 
resources could reduce the oversight of other categories of providers 
and endanger the health and safety of program beneficiaries.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           08/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Undetermined


Agency Contact:
Amber L. Wolfe
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Center for Medicaid and State Operations
7500 Security Boulevard
S2-12-25
Baltimore, MD 21244
Phone: 410 786-6773
Email: [email protected]
RIN: 0938-AN62
_______________________________________________________________________



HHS--CMS

                              -----------

                            FINAL RULE STAGE

                              -----------




66. MEDICARE ADVANTAGE PROGRAM--TITLE II (CMS-4069-F)
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


PL108-173, MMA


CFR Citation:


42 CFR 417; 42 CFR 422


Legal Deadline:


None


Abstract:


This final rule implements title II of the Medicare Modernization Act 
establishing the Medicare Advantage program that will replace the 
existing Medicare+Choice program. Medicare Advantage offers improved 
managed care plans with coordinated care and competitive bidding, to 
promote greater efficiency and responsiveness to Medicare 
beneficiaries.


Statement of Need:


Implementation of the Medicare Advantage (MA) Program is required by 
section 201 of the Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003. The MA program replaces the Medicare+Choice 
(M+C) program established under part C of title XVIII of the Social 
Security Act. The primary goal of the MA program is to expand health 
plan choices available to Medicare beneficiaries in areas that 
previously had no private plans and in areas with few competing plans. 
Beneficiary choice should be enhanced by the introduction of new types 
of plans, including specialized MA plans, and regional plans that are 
structured as preferred provider organizations. The MA program becomes 
effective January 1, 2006.


Summary of Legal Basis:


Section 201 of the Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003 (Pub. L. 108-173).


Alternatives:


None.


Anticipated Cost and Benefits:


In general, the MA program will have a positive impact on 
beneficiaries.

[[Page 72743]]

Transfer payments from the Federal Government will go towards the 
provision of additional benefits to enrollees of health plans and 
reduced out-of-pocket costs, including reduced part B and part D 
premiums for these enrollees. The law will result in increased revenue 
for participating private plans for the provision of the basic Medicare 
benefit and the provision of additional benefits. This is expected to 
help improve the availability of health plan choices for beneficiaries.


Risks:


Risks include not publishing the final regulation in time to allow 
prospective local and regional MA plans to participate in the MA 
program. Prospective MA plans need to apply to become an MA plan and 
prepare bids in the spring of 2005. This is a particular concern for MA 
organizations considering offering new types of plans, such as MA 
regional PPOs and specialized MA plans. If plans choose not to 
participate due to a delay in publishing the final regulation, there 
may be the risk of low participation in the MA program for 2006 and 
beneficiaries will continue to have little choice or only the choice of 
fee-for-service in many parts of the country. Because expanded choice 
of plans for beneficiaries is the cornerstone of the MMA legislation, 
this is a big risk.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            69 FR 46866                                    08/03/04
NPRM Comment Period End                                        10/04/04
Final Action                                                   01/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Jane Andrews
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Center for Beneficiary Services
7500 Security Boulevard
C4-13-01
Baltimore, MD 21244-1850
Phone: 410 786-3133
Email: [email protected]
RIN: 0938-AN06
_______________________________________________________________________



HHS--CMS



67. MEDICARE DRUG BENEFIT EFFECTIVE CALENDAR YEAR 2006--TITLE I (CMS-
4068-F)
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


PL 108-173, MMA


CFR Citation:


42 CFR 417; 42 CFR 423


Legal Deadline:


None


Abstract:


This final rule implements title I of the Medicare Modernization Act, 
which establishes a new voluntary outpatient prescription drug benefit 
under a new Medicare part D, beginning January 1, 2006. Coverage for 
the drug benefit will be provided by private prescription drug plans 
(PDPs) that offer drug only coverage, or through Medicare Advantage 
plans or preferred provider plans (PPOs) that will offer prescription 
drug and non-drug coverage. Plans will offer a standard drug benefit 
but have the flexibility to vary the drug benefit within actuarial 
equivalency parameters. Assistance with premiums and cost sharing will 
be provided to eligible low-income beneficiaries.


Statement of Need:


Implementation of the Medicare Prescription Drug Benefit is required by 
section 101 of the Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003 (MMA). The addition of a prescription drug 
benefit to Medicare represents a landmark change to the Medicare 
program that will significantly improve the health care coverage 
available to millions of Medicare beneficiaries. The MMA specifies that 
the prescription drug benefit program will become available to 
beneficiaries beginning on January 1, 2006.


Summary of Legal Basis:


Section 101 of the Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003 (Pub. L. 108-173).


Alternatives:


None.


Anticipated Cost and Benefits:


The Prescription Drug benefit will have a positive impact on 
beneficiaries. All Medicare beneficiaries will have access to a 
voluntary drug benefit. A typical beneficiary--not eligible for 
additional low-income benefits--with no coverage today will see their 
total spending on drugs drop by 53 percent. In addition, it is 
estimated that nearly 11 million beneficiaries with limited means will 
participate in the low-income subsidy, receiving substantial additional 
help from Medicare. Beneficiaries will see lower drug costs as a result 
of price negotiation and coordination of health services by the 
prescription drug plans and Medicare Advantage plans.


Risks:


Risks include not publishing the final regulation in time to allow 
prospective prescription drug plans (PDPs) to participate. Prospective 
PDPs need to apply to become a Medicare PDP and prepare bids in the 
spring of 2005. This is a particular concern since this is a brand new 
program and benefit. If plans choose not to participate due to a delay 
in publishing the final regulation, there is the risk of low 
participation in the part D program for 2006 and beneficiaries will be 
without the drug benefit. Because the drug benefit is the cornerstone 
of the MMA legislation, this is a big risk.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            69 FR 46632                                    08/03/04
NPRM Comment Period End                                        10/04/04
Notice          69 FR 45822                                    07/30/04
Final Action                                                   01/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses, Governmental Jurisdictions


Government Levels Affected:


Federal, State, Tribal


Federalism:


 This action may have federalism implications as defined in EO 13132.

[[Page 72744]]

Agency Contact:
Tracey McCutcheon
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Center for Beneficiary Services
7500 Security Boulevard
C4-25-02
Baltimore, MD 21244
Phone: 410 786-6715
Email: [email protected]
Related RIN: Related to 0938-AN07
RIN: 0938-AN08
BILLING CODE 4150-24-S

[[Page 72745]]




DEPARTMENT OF HOMELAND SECURITY (DHS)



Statement of Regulatory Priorities
 The attack on our homeland of September 11, 2001, was an assault on 
the ideas that make our Nation great. We were reminded that the values 
we hold dear must not be taken for granted. From these tragic events, a 
stronger union has emerged. Our citizens, and those of countries around 
the world, renewed their commitment to this Nation and the values for 
which it stands. In January 2003, the United States Government 
established the Department of Homeland Security (the Department or 
DHS), the Nation's 15th and newest Cabinet department, consolidating 22 
previously disparate agencies and 180,000 employees under one unified 
organization. By rapidly and efficiently setting up the needed 
infrastructure, the Department was able to remain focused on its 
overriding and urgent mission: securing the American homeland and 
protecting the American people. Our Department quickly developed the 
high-level strategic thinking embodied in our strategic management 
initiatives and plans. Our Mission Statement is our guiding principle: 
We are charged to lead the unified national effort to secure America. 
We will prevent and deter terrorist attacks and protect against and 
respond to threats and hazards to the Nation. We will ensure safe and 
secure borders, welcome lawful immigrants and visitors, and promote the 
free flow of commerce.
 DHS' Strategic Plan supports the President's National Strategy for 
Protecting Homeland Security. Our Strategic Plan governs the 
development of DHS' strategies, programs and projects, and ultimately 
is reflected in the Department's budget and regulatory agenda. DHS' 
Strategic Plan is posted on the Department's Web site: http://
www.dhs.gov/dhspublic/interapp/editorial/editorial--0413.xml.
 The Strategic Plan reflects the determination of our Nation to prevail 
against terror, to protect our homeland and to create a better world in 
the process. The Department strives for organizational excellence and 
uses a centralized and unified approach in managing its regulatory 
resources. Each regulatory project is linked to the Department's 
Strategic Plan and departmental goals and objectives. Senior Department 
leadership reviews each regulatory project, including the Unified 
Agenda, to ensure that the project fosters and supports the 
Department's Strategic Goals outlined in DHS' Strategic Plan. DHS' 
Strategic Goals are:
AWARENESS--Identify and understand threats, assess vulnerabilities, 
determine potential impacts, and disseminate timely information to our 
homeland security partners and the American public.
PREVENTION--Detect, deter, and mitigate threats to our homeland.
PROTECTION--Safeguard our people and their freedoms, critical 
infrastructure, property, and the economy of our Nation from acts of 
terrorism, natural disasters, or other emergencies.
RESPONSE--Lead, manage, and coordinate the national response to acts of 
terrorism, natural disasters, or other emergencies.
RECOVERY--Lead national, State, local, and private sector efforts to 
restore services and rebuild communities after acts of terrorism, 
natural disasters, or other emergencies.
SERVICE--Serve the public effectively by facilitating lawful trade, 
travel, and immigration.
ORGANIZATIONAL EXCELLENCE--Value our most important resource, our 
people. Create a culture that promotes a common identity, innovation, 
mutual respect, accountability, and teamwork to achieve efficiency, 
effectiveness, and operational synergies.
 The Department ensures that all of its regulatory initiatives are 
aligned with its guiding principles to: protect civil rights and civil 
liberties, integrate our actions, build coalitions and partnerships, 
develop human resources, innovate, and be accountable to the American 
public. The Department values public involvement in the development of 
its regulatory plan, Unified Agenda, and regulations.
 Last year, the Department partnered with two agencies leading the 
Federal electronic docket management initiative: the Environmental 
Protection Agency (EPA) and the Department of Transportation (DOT). 
Both agencies agreed to host selected DHS regulations on their docket 
management Web sites. The Department chose four significant regulations 
to pilot these docketing systems: Human Resources Management System 
Regulations and ``US-VISIT'' are on the EPA's EDocket; DHS Supplement 
to the Federal Acquisition Regulations and the regulations to Support 
Antiterrorism by Fostering Effective Technologies Act (SAFETY ACT) are 
hosted on the DOT Docket Management System (DMS). By using these two 
docketing systems, DHS provided optimal access to the public to review 
and comment on these regulatory proposals. In fact, the Human Resources 
Management System Regulations received nearly 4,000 public comments. 
Our ability to use existing electronic docketing systems has maximized 
departmental resources and significantly enhanced the regulatory 
process. The Department has decided that, since the U.S. Coast Guard 
and the Transportation Security Administration are legacy DOT agencies 
and that members of the public that ordinarily participate in their 
rulemaking process are accustomed to using DOT's DMS, those two 
agencies will remain on DOT's DMS until full migration to the Federal 
docketing management system. The remaining Department Headquarters and 
organizational elements have joined EPA's Federal EDocket system and 
members of the public can expect to see these elements using EPA's 
Federal EDocket system for those regulations listed in the Unified 
Agenda. The EPA Federal EDocket Web site is http://www.epa.gov/
feddocket. The DOT DMS Web site for the U.S. Coast Guard and the 
Transportation Security Administration regulations is dms.dot.gov. The 
public may also provide public comments to DHS' regulations through 
www.regulations.gov. We strongly encourage public participation in DHS' 
upcoming regulatory initiatives.
Office of the Secretary
 DHS is managed by Tom Ridge, the Secretary of the Department of 
Homeland Security; Admiral James Loy, the Deputy Secretary; five Under 
Secretaries (Asa Hutchinson, Under Secretary for the Directorate of 
Border and Transportation Security; Michael Brown, Under Secretary for 
Emergency Preparedness and Response; Janet Hale, Under Secretary for 
Management; General Frank Libutti, Under Secretary for Information 
Analysis and Infrastructure Protection; and Charles McQueary, Under 
Secretary for Science and Technology) and by those persons leading the 
independent organizational elements who report directly to the 
Secretary and the Deputy Secretary (Admiral Thomas Collins, Commandant 
of the U.S. Coast Guard; Eduardo Aguirre, Jr., Director of the U.S. 
Citizenship and Immigration Services agency are two independent 
elements with rulemaking authority). Joe Whitley, the General Counsel 
to the Department, manages the Department's regulatory plan and Unified 
Agenda.

[[Page 72746]]

 The Office of the Secretary's regulatory plan includes regulations 
sponsored by the Department's Under Secretaries with the exception of 
the Under Secretary for Emergency Preparedness and Response (EP&R). The 
Under Secretary for EP&R is also the head of the Federal Emergency 
Management Agency (FEMA) and so the EP&R regulatory plan is the same as 
FEMA's. The U.S. Coast Guard and the U.S. Citizenship and Immigration 
Services are two independent organizational elements that exercise 
their statutory authorities, in part, through regulation. Their 
regulatory plans are discussed separately below. The Bureau of Customs 
and Border Protection, the Bureau of Immigration and Customs 
Enforcement, and the Transportation Security Administration's 
regulatory plans will also be discussed separately.
 During fiscal year 2005, the Office of the Secretary expects to 
complete work on a regulatory program to implement the United States 
Visitor and Immigrant Status Indicator Technology (US-VISIT) program. 
US-VISIT is an integrated, automated entry-exit system that records the 
arrival and departure of aliens; verifies aliens' identities, and 
authenticates aliens' travel documents through comparison of 
biometrics. US-VISIT will enhance national security while facilitating 
legitimate travel and trade through our borders. This regulatory 
program supports the Department's Strategic Goals of awareness, 
prevention, and protection by securing our borders against terrorists 
who intend to harm the United States.
 The Department expects to finalize the interim rule on Procedures for 
Handling Critical Infrastructure Information (CII). This rulemaking 
establishes uniform procedures for the receipt, care, and storage of 
CII voluntarily submitted to the Federal Government. The procedures 
apply to all Federal agencies that receive, care for, or store CII 
voluntarily submitted to the Federal Government. It supports the 
Department's Strategic Goals of awareness, prevention, protection, and 
response by identifying and assessing the vulnerability of critical 
infrastructure and key assets.
 The Department and the Office of Personnel Management expect to 
finalize their proposed regulations to establish a new human resources 
management system within DHS, as authorized by the Homeland Security 
Act of 2002. The affected subsystems include the systems governing 
basic pay, classification, performance management, labor relations, 
adverse actions, and employee appeals. This regulatory initiative 
supports DHS' Strategic Goal of organizational excellence by valuing 
our most important resource, our people. It is expected that the 
regulation will assist the Department by providing a coherent human 
resources management mechanism that maximizes efficiencies, 
effectiveness, and operational synergies promoting the Department's 
Strategic Goal of organizational excellence.
 The Department also intends to finalize its interim rule on the SAFETY 
ACT. The SAFETY ACT regulation implements the Support Anti-Terrorism by 
Fostering Effective Technology Act found at subtitle G of the Homeland 
Security Act of 2002 (Homeland Security Act). DHS published an interim 
final rule with request for comments implementing the SAFETY ACT 
provision. This rule provides critical incentives for the development 
and deployment of antiterrorism technologies by providing liability 
protections for sellers of ``qualified antiterrorism technologies'' and 
others.
 The Department intends to publish implementing regulations under 
section 892 of the Homeland Security Act addressing sharing sensitive 
homeland security information (SHSI). The regulations will propose 
procedures for the identification, sharing, and safeguarding of 
homeland security information that is sensitive but unclassified. These 
procedures will apply to all agencies of the Federal Government and may 
apply to State and local governments and first responders. This 
regulatory initiative supports DHS' Strategic Goals of awareness, 
prevention, protection, response and recovery by providing a 
comprehensive and unified mechanism of sharing sensitive homeland 
security information at Federal, State, and local levels.
U.S. Coast Guard
 The U.S. Coast Guard (USCG) is a military, multi-mission, and maritime 
agency. Its statutory responsibilities include ensuring marine safety 
and security, preserving maritime mobility, protecting the marine 
environment, enforcing U.S. laws and international treaties, and 
performing search and rescue. The Coast Guard's Strategic Goals are 
aligned with the Department's Strategic Goals. In performing its 
duties, the Coast Guard has established certain priorities for its 
regulatory program and has identified which of its five strategic 
goals--maritime safety, protection of natural resources, maritime 
security, maritime mobility, and national defense--the project 
supports.
 The Coast Guard continues to use plain language in its notices and 
rulemaking documents to promote better understanding of regulations and 
increased public participation in its rulemakings. The Coast Guard 
encourages early public involvement in this process and has particular 
concern for the impacts its rules have on small businesses. It has 
supported the e-rulemaking initiative, and, on the first day of Federal 
Register publication of each rulemaking project, the public can submit 
comments electronically and view agency documents and public comments 
on the Department of Transportation's Document Management System, which 
is available online at The Coast Guard endeavors to reduce the 
paperwork burden it places on the public and strives to issue only 
necessary regulations that are tailored to impose the least burden on 
society. The 60 rulemaking projects described in the Unified Agenda, 
and both of the rules appearing on The Regulatory Plan support our 
strategic goals and reflect the Department's and the Coast Guard's 
regulatory policies.
 As part of its response to the terrorist attacks of September 11, 
2001, after conducting public workshops and meetings, the Coast Guard, 
on July 1, 2003, issued six separate, but complementary, maritime 
security temporary interim rules designed to implement Maritime 
Transportation Security Act of 2002 (MTSA) mandates regarding maritime 
facilities, vessels, and ports and to require automatic identification 
equipment on certain vessels. Under authority of MTSA, the Coast Guard 
superceded these temporary interim rules with final rules that were 
published on October 22, 2003 (68 FR 60448). Also in response to 9/11, 
Coast Guard Captains of the Port have issued rules establishing 
security zones around nuclear power plants, airports, cruise ships, 
liquefied natural gas vessels, and maritime facilities.
 Its post-September 11, 2001 emphasis on maritime security and national 
defense has not prevented the Coast Guard from carrying out its other 
regulatory responsibilities. Coast Guard Headquarters has issued many 
rules or proposed rules that are not security-related, as indicated by 
the wide range of topics covered in its 60 rulemaking projects in the 
final-rule, long-term actions, or proposed-rule stages in the Unified 
Agenda. Of particular interest to the Coast Guard are the two rules 
appearing in The Regulatory Plan: Post

[[Page 72747]]

Casualty Drug and Alcohol Testing and Commercial Fishing Industry 
Vessels. These rules promote the Department's Strategic Goals of 
protection by providing regulatory measures aimed at protecting the 
marine environment, living marine resources, and maritime safety.
 The Coast Guard, through the rulemaking projects identified in The 
Regulatory Plan and the Unified Agenda, plans to continue to meet its 
multi-mission, regulatory obligations as reflected in its strategic and 
policy goals and the goals of the President's Six Point Plan for 
Economic Growth by streamlining its regulations.
U.S. Citizenship and Immigration Services
 The U.S. Citizenship and Immigration Services' (USCIS) mission is to 
restore public confidence in the integrity of America's immigration 
services by making certain that those immigrant applicants meeting our 
statutory and regulatory requirements, such as those provided by the 
Immigration and Nationalization Act and its implementing regulations, 
duly receive all rights and benefits granted by law. USCIS will ensure 
that it issues benefits only to eligible individuals.
Strengthening Immigration Services
 USCIS' key regulatory initiatives that govern nonimmigrant classes and 
admission requirements focus on eliminating the backlog of processing 
pending applications and petitions. Promulgation of these rules will 
help in streamlining processing procedures and the paperwork burden 
thereby improving customer service. These regulations are the Removal 
of the Standardized Request for Evidence Processing Timeframe; 
Petitions for Employment Based Immigrants; Removal of Limitations on 
the Validity Period for Certain Employment Authorization Documents; and 
Affidavits of Support on Behalf of Immigrants. Together, these rules 
will amend various USCIS regulatory provisions to: (1) remove fixed 
regulatory timeframes for responses to requests for evidence or notices 
of intent to deny; (2) remove fixed validity periods for employment 
authorization documents; (3) modify the evidentiary requirements for 
employment-based petitions to focus on evidence establishing the bona 
fides of the U.S employer and the validity of the job offered; and (4) 
clarify the standards for adjudication of Affidavits of Support that 
petitioning relatives must file to establish that the beneficiary will 
not become a public charge. These regulatory projects foster the 
President's SixPoint Plan for economic growth by streamlining 
regulatory requirements and are aligned with the Department's Strategic 
Goal of service and organizational excellence. These proposed rules 
will give USCIS the flexibility to set more appropriate timeframes for 
evidence requests and document validity periods as well as to clarify 
the standards for adjudication of various benefit applications and 
petitions, thereby enabling USCIS to reduce its backlog and benefit 
processing times.
 An additional key regulatory initiative is the streamlining of the 
nonimmigrant regulations codified in 8 CFR part 214, which have grown 
in size and complexity during the past 15 years as Congress has added 
at least 10 new nonimmigrant classes and expanded the requirements and 
restrictions on many of the existing classes. This regulatory 
initiative provides for a comprehensive reorganization, streamlining, 
and rewriting of 8 CFR part 214 in plain language. This regulation is 
titled Restructuring the Nonimmigrant Regulations and furthers the 
President's Six Point Plan for economic growth.
 There are a number of other planned regulatory actions focused on 
improving benefit processing and adjudication services, preventing 
fraudulent claims, and ensuring that USCIS issues ben efits only to 
eligible individuals. These and other planned rulemakings are 
delineated in USCIS' agenda. These proposed rules will amend various 
UCSIS regulatory provisions to: (1) clarify the procedures for 
individuals to seek review of adverse decisions issued by USCIS and the 
standards for adjudication of such requests; (2) allow USCIS to 
precertify certain U.S. employers' ability to pay an alien or that the 
job offered by the U.S. employer is a specialty occupation; (3) extend 
the time period within which an employer may file a petition for an 
alien with extraordinary ability or who is an athlete or entertainer; 
(4) modify USCIS' procedures to ensure that all background checks are 
completed on individual aliens before USCIS issues evidence of alien 
registration; and (5) standardize adjudication of all requests for 
waiver of fees.
 By clarifying the standards for adjudication of various benefit 
applications and petitions, extending the timeframes for filing of 
petitions, and eliminating the need for certain employers to 
reestablish that they have met certain requirements for filing a 
petition every time a new petition is filed, USCIS is able to 
streamline its adjudication process, thus reducing its backlog through 
faster adjudication, and ultimately decreasing benefit processing 
times. USCIS believes that these regulatory initiatives will improve 
the processing of applications and petitions by streamlining the 
processes and thereby helping to alleviate the backlog. USCIS further 
believes that these initiatives have appropriate safeguards to prevent 
fraud and abuse. These regulatory activities foster many of the 
Department's Strategic Goals: awareness, prevention, protection, and 
organizational excellence by placing USCIS in a better position to 
safeguard against any risk that may be posed by unlawful applicants to 
national security or public safety by ensuring that documents are 
issued after the completion of required background and security checks. 
This initiative also fosters the President's Six Point Plan for 
Economic Growth.
Emergency Preparedness and Response / Federal Emergency Management 
Administration
 The mission of the Federal Emergency Management Agency (FEMA) is: ``To 
lead the Nation to prepare for, mitigate the effects of, respond to, 
and recover from major disasters and emergencies, both natural and man-
made, including acts of terrorism.'' FEMA is charged with developing 
and maintaining an integrated, nationwide operational capability to 
respond to and recover from disasters and emergencies, regardless of 
their cause, in partnership with other Federal agencies, State and 
local governments, volunteer organizations, and the private sector. 
FEMA coordinates and implements the Federal response to disasters 
declared by the President. FEMA also has the responsibility to ensure 
effective emergency preparedness. The agency is led by the Under 
Secretary for Emergency Preparedness and Response, Under Secretary 
Michael Brown.
 The 9/11 Heroes Stamp Act of 2001 directed the U.S. Postal Service to 
issue a postal stamp and distribute the proceeds through FEMA to the 
families of emergency relief personnel killed or permanently disabled 
while serving in the line of duty in connection with the terrorist 
attacks of September 11, 2001. RIN 1660-AA34, Assistance Program Under 
the 9/11 Heroes Stamp Act of 2001, establishes the mechanism through 
which FEMA will distribute these funds. This regulation fosters the 
Department's Strategic Goal of recovery by assisting the families of 
emergency

[[Page 72748]]

relief personnel who served in the line of duty on 9/11 to rebuild 
their lives. RIN 1660-AA07, National Urban Search and Rescue Response 
System, would standardize the financing, administration, and operation 
of the National Urban Search and Rescue Response System; a cooperative 
effort of FEMA, participating State emergency management agencies, and 
local public safety agencies across the country.
Directorate of Border and Transportation Security
 The Directorate of Border and Transportation Security (BTS) is 
comprised of the law enforcement agencies (with the exception of the 
U.S. Coast Guard and the U.S. Secret Service), three of which are 
contributors to The Regulatory Plan; the Bureau of Customs and Border 
Protection, led by Robert Bonner; the Bureau of Immigration and Customs 
Enforcement, headed by Michael Garcia; and the Transportation Security 
Administration, headed by Admiral David Stone.
Bureau of Customs and Border Protection
 On November 25, 2002, the President signed the Homeland Security Act 
of 2002 (Homeland Security Act) establishing the Department of Homeland 
Security. Under section 403(1) of the Homeland Security Act, the United 
States Customs Service, including functions of the Secretary of the 
Treasury relating thereto, transferred to the Secretary of Homeland 
Security. As part of the DHS reorganization, the Customs Service 
inspection and trade functions were combined with the immigration and 
agricultural inspection functions and the Border Patrol and transferred 
into the Bureau of Customs and Border Protection (CBP). It is noted 
that certain regulatory authority of the United States Customs Service 
relating to customs revenue functions was retained by the Department of 
the Treasury (see the Department of the Treasury regulatory plan).
 CBP is the Federal agency principally responsible for the security of 
our Nation's borders, both at and between the ports of entry and at 
official crossings into the United States. CBP must accomplish its 
border security and enforcement mission without stifling the flow of 
legitimate trade and travel. The primary mission of CBP is its homeland 
security mission, that is, to prevent terrorists and terrorist weapons 
from entering the United States. An important aspect of this priority 
mission involves improving security at our borders and ports of entry, 
but it also means extending our zone of security beyond our physical 
borders.
 CBP is also responsible for administering laws concerning the 
importation into the United States of goods and enforcing the laws 
concerning the entry of persons into the United States. This 
responsibility includes regulating and facilitating international 
trade; collecting import duties; enforcing U.S. trade, immigration and 
other laws of the United States at our borders; inspecting imports, 
overseeing the activities of persons and businesses engaged in 
importing; enforcing the laws concerning smuggling and trafficking in 
contraband; apprehending individuals attempting to enter the United 
States illegally; protecting our agriculture and economic interests 
from harmful pests and diseases; servicing all people, vehicles, and 
cargo entering the United States; maintaining export controls; and 
protecting American businesses from theft of their intellectual 
property.
 In carrying out its priority mission, CBP's goal is to facilitate the 
processing of legitimate trade and people efficiently without 
compromising security. During the past fiscal year, consistent with its 
primary mission of homeland security, CBP issued a final rule that 
increases advance data regarding incoming conveyances and goods. In 
accordance with the Trade Act of 2002, this final rule requires 
operators of sea vessels, aircraft, trucks, and trains to transmit 
advance information electronically to CBP pertaining to cargo before 
the cargo is either brought into or sent from the United States on 
those conveyances.
 During fiscal year 2005, CBP plans to enhance homeland security 
further by issuing several other regulatory documents that will require 
advance information. CBP plans to finalize the following interim final 
rules: Passenger and Crew Manifests Required for Passenger Flights in 
Foreign Air Transportation to the United States (Passenger and Crew 
Manifests rule) and Passenger Name Record Information Required for 
Passengers on Flights in Foreign Air Transportation To or From the 
United States (Passenger Name Record Information rule). The Passenger 
and Crew Manifests rule requires that each air carrier, foreign and 
domestic, operating a passenger flight in foreign air transportation to 
the United States electronically transmit to CBP in advance of arrival 
a passenger and crew manifest that contains certain specified 
information. The Passenger Name Record Information rule requires that 
each air carrier must provide CBP with electronic access to Passenger 
Name Record information contained in the carrier's automated 
reservation system and/or departure control system that sets forth the 
identity and travel plans of any passengers on flights in foreign air 
transportation either to or from the United States. Both of these rules 
foster DHS' Strategic Goals of awareness and prevention.
 In addition to its plans to continue issuing regulations to enhance 
border security, CBP, during fiscal year 2005, expects to continue to 
issue regulatory documents that will facilitate legitimate trade and 
implement trade benefit programs. Discussion of CBP regulations 
regarding the customs revenue function is contained in the regulatory 
plan of the Department of the Treasury. Also, CBP expects to issue 
regulatory projects reflecting CBP's responsibility for the immigration 
inspection function.
Bureau of Immigration and Customs Enforcement
 The Bureau of Immigration and Customs Enforcement (ICE), the largest 
investigative arm of the Department, is responsible for identifying and 
preventing security vulnerabilities to the Nation's border, economic, 
transportation, and infrastructure. Its mission is to prevent acts of 
terrorism by targeting the people, money, and materials that support 
terrorist and criminal activities. Established to combat the criminal 
and national security threats emergent in a post 9/11 environment, ICE 
combines a new investigative approach with new resources to provide 
unparalleled investigation, interdiction and security services to the 
public and our law enforcement partners in the Federal and local 
sectors.
 ICE will be pursuing rulemaking to implement major components of the 
President's and the Department's Strategic Goals. ICE will continue to 
promulgate regulations focused on addressing control issues for over 
500,000 international students attending colleges and universities in 
the United States and a similar number of exchange visitors entering 
the United States through the Department of State's (DOS) ``J'' visa 
program. This regulatory action will foster the Department's Strategic 
Goals of awareness and prevention.
 In an effort to streamline the removal process of persons who no 
longer have immigration status, ICE will promulgate a rule that 
requires aliens who become subject to a final order of removal to 
surrender themselves to the ICE within 30 days thereafter. This rule 
provides

[[Page 72749]]

that aliens who are given notice of the mandatory duty to surrender and 
later fail to comply with the surrender obligation will be denied all 
discretionary immigration benefits for the remainder of their presence 
in the United States and for 10 years after their departure. This 
action enhances the integrity of the removal process by shifting the 
burden upon termination of removal proceedings--eliminating the 
requirement that ICE seek out those subject to final removal orders--
and instead requiring that such persons present themselves for removal. 
The surrender requirement will apply to aliens who receive notice of 
the obligation in the course of their immigration proceedings or 
concurrently with the final order of removal. This regulatory 
initiative promotes the Department's Strategic Goals of awareness and 
prevention.
 Concurrently, ICE has launched an initiative to address the fact that 
large numbers of aliens who already have final removal orders have not 
departed the United States. Such aliens, termed absconders, are the 
subject of the ICE subregulatory Absconder Apprehension Initiative 
(AAI), which is designed to enhance the ability of ICE to apprehend 
absconders. In AAI, the agency has begun reviewing the files of 
absconders to enter appropriate records into the National Crime 
Information Center (NCIC) database so that they may be apprehended when 
encountered by Federal, State, or local law enforcement officials. This 
effort supplements efforts being undertaken by ICE to use recent 
resource enhancements to apprehend those absconders whom ICE can 
locate.
Transportation Security Administration
 In response to the September 11, 2001, terrorist attacks in the United 
States, and with the potential for future attacks in this country, 
Congress enacted the Aviation and Transportation Security Act (ATSA), 
Public Law 107-71, 115 Stat. 597 on November 19, 2001. ATSA established 
the Transportation Security Administration (TSA) to protect the 
transportation system----a complex ``system of systems'' comprised of 
aircraft, ships, and rail and motor vehicles; airports, seaports, and 
transshipment facilities; roads, railways, bridges, and pipelines; and 
supporting infrastructures----and ensure the freedom of movement for 
people and commerce. Initially, TSA was created as an agency within the 
Department of Transportation (DOT). As of March 1, 2003, the Homeland 
Security Act transferred TSA from DOT to the Department.
 Much of TSA's initial efforts focused on meeting congressionally 
mandated aviation-security objectives. We have made significant 
progress and will continue to fulfill our obligations in the aviation 
sector. However, we have expanded our efforts to address threats across 
all modes of transportation and to provide world-class security and 
customer service to travelers and shippers. As we work to meet the 
immediate needs of the transportation sector, we continue to develop 
and implement the strategies, through its people, processes, and 
technology that enable us to perform our daily activities while 
ultimately preparing us for the future.
 TSA's Strategic Goals are aligned with the Department's Strategic 
Goals. In fiscal year 2005, TSA will emphasize regulatory efforts to 
implement transportation security enhancements responsive to 
Presidential leadership, DHS priorities, Congressional mandates, and 
public input, particularly the recommendations of the ``National 
Commission on Terrorist Attacks Upon the United States'' (the 9/11 
Commission Report). In defining appropriate security enhancements, TSA 
will continue testing concepts, such as Registered Traveler, Secure 
Flight, and the Transportation Worker Identification Credential, to 
demonstrate feasibility and obtain public input prior to national 
implementation and rulemaking. These regulatory initiatives promote 
DHS' Strategic Goals of awareness, prevention, and protection by 
providing important information on certain persons using or are 
employed on our transportation systems. TSA is partnering with other 
DHS organizational elements, such as the Bureau of Immigration and 
Customs Enforcement, and the U.S. Coast Guard, and with other Federal, 
State, and local agencies, to achieve common objectives and assure a 
uniform and appropriate standard of transportation security for the 
benefit of the American public.
 TSA is broadening targeted security screening of persons to include 
land transportation elements, foster development of methods to enhance 
screening of cargo in surface transport, and will publish a notice of 
proposed rulemaking to enhance air cargo security. These regulatory 
projects will increase our ability to identify and deter threats to our 
homeland, furthering DHS' Strategic Goals of awareness, prevention, and 
protection. In appropriate instances, TSA will seek authority to levy 
fees to offset all or a portion of the cost of certain security 
enhancements, such as certain background checks, and will propose a 
revised formula for computing the Aviation Security Infrastructure Fee 
(ASIF).
 TSA will act to assure that sensitive security information (SSI) 
concerning all modes of transportation is collected when necessary, 
handled appropriately, shared among appropriate persons, and protected 
from improper disclosure or use. TSA will also take steps to assure 
that requirements directly affecting the security of the U.S. air 
transportation industry will be applied wherever the security of U.S. 
personnel or assets is at stake, and that industry personnel in 
identified critical transportation activities receive appropriate 
security training. Also, TSA will codify security requirements 
applicable to designated airports in the National Capitol Area. These 
regulatory initiatives promote DHS' Strategic Goals of awareness, 
prevention, protection, response, and organizational excellence by 
applying the appropriate measures to collect and disseminate SSI, and 
providing appropriate security training to industry personnel.
_______________________________________________________________________



DHS--Office of the Secretary (OS)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




68.  HOMELAND SECURITY INFORMATION SHARING
Priority:


Other Significant. Major status under 5 USC 801 is undetermined.


Unfunded Mandates:


Undetermined


Legal Authority:


PL 107-296; 116 Stat 2135; 6 USC 301


CFR Citation:


Not Yet Determined


Legal Deadline:


None


Abstract:


This proposed regulation will establish procedures for sharing, 
identifying and safeguarding, processing and handling, Homeland 
Security Information between agencies and appropriate State and local 
personnel.

[[Page 72750]]

Statement of Need:


This proposed rule will implement section 892 of the Homeland Security 
Act (HSA) addressing sharing sensitive homeland security information. 
The regulations will propose procedures for the identification, 
sharing, and safeguarding of homeland security information. These 
proposed procedures will apply to all agencies of the Federal 
Government, State and local governments, and first responders. The 
Department will seek comment on proposed procedures to facilitate more 
robust, effective, and timely sharing of homeland security information 
among agencies of the Federal Government and between the Federal 
Government and State and local personnel engaged in homeland security 
activities. Section 892 of the HSA provides explicit statutory 
authority to realize the objectives of the President's National 
Homeland Security Strategy and the recommendations of the 9/11 
Commission Report by mandating clear procedures to establish the extent 
of sharing for homeland security information and govern how the actual 
sharing of the information will be accomplished. These regulations will 
assist the Federal Government, State and local governments, and first 
responders to effectively defend against and respond to potential 
terrorist attacks.


Summary of Legal Basis:


This regulation is needed to assist the Department of Homeland Security 
in meeting its statutory obligation under the Homeland Security Act to 
share sensitive homeland security information.


Alternatives:


The Department of Homeland Security believes that there is no 
alternative to sharing sensitive homeland security information. The 
statute mandates the sharing and the 9/11 Commission recommends its 
sharing.


Anticipated Cost and Benefits:


The Department of Homeland Security is still considering the costs 
associated with the identification, protection, storing, and sharing of 
homeland security information. We do not have a determination at this 
point. The benefits of sharing homeland security information is to 
provide Federal agencies, State and local governments, and first 
responders better information so that they may detect and prevent 
terrorists attacks.


Risks:


This regulatory project will complement other DHS initiatives designed 
to detect, deter and prevent terrorist attacks.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/04
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


Federal, Local, State


Federalism:


 This action may have federalism implications as defined in EO 13132.


Agency Contact:
Eric Werner
Department of Homeland Security
Office of the General Counsel
Washington, DC 20528
Phone: 202 401-0775
Email: [email protected]
RIN: 1601-AA25
_______________________________________________________________________



DHS--OS

                              -----------

                            FINAL RULE STAGE

                              -----------




69. PROCEDURES FOR HANDLING CRITICAL INFRASTRUCTURE INFORMATION
Priority:


Other Significant


Legal Authority:


PL 107-296, 116 Stat 2135; 5 USC ch 1, sec 301; Section 214 of The 
Homeland Security Act of 2002


CFR Citation:


6 CFR 29


Legal Deadline:


None


Abstract:


This notice of proposed rulemaking establishes the procedures necessary 
to fulfill the provisions of section 214(e) of the Critical 
Infrastructure Information (CII) Act of 2002. This regulation 
establishes uniform procedures for the receipt, care, and storage of 
CII voluntarily submitted to the Federal Government. These procedures 
apply to all Federal agencies that receive, care for, or store CII 
voluntarily submitted to the Federal Government pursuant to the CII Act 
of 2002 (6 U.S.C. 214). In addition, these procedures apply to United 
States Government contractors, to foreign, State, and local 
governments, and Government authorities, pursuant to their express 
agreements.


Statement of Need:


This final rule will establish procedures to implement section 214 of 
the Homeland Security Act of 2002 regarding the receipt, care, and 
storage of critical infrastructure information voluntarily submitted to 
the Department of Homeland Security. The protection of critical 
infrastructure reduces the vulnerability of the United States to acts 
of terrorism. The purpose of the regulation is to encourage private 
sector entities to share information pertaining their particular and 
unique vulnerabilities, as well as those that may be systemic and 
sector wide. As part of its responsibilities under the Homeland 
Security Act of 2002, this information will be analyzed by the 
Department of Homeland Security to develop a more thorough 
understanding of the critical infrastructure vulnerabilities of the 
Nation. By offering an opportunity for protection from disclosure under 
the Freedom of Information Act that qualifies under section 214, the 
Department will assure private sector entities that their information 
will be safeguarded from abuse by competitors or the open market.


Summary of Legal Basis:


This regulation is needed to finalize the interim final rule that 
implements section 214 of the Homeland Security Act by establishing 
uniform procedures for the receipt, care, and storage of critical 
infrastructure Information.


Alternatives:


The Department of Homeland Security believes that there is no 
alternative to protecting critical infrastructure information. Section 
214 of the Homeland Security Act instructs DHS to establish uniform 
procedures for the receipt, care, and storage of critical 
infrastructure information that is voluntarily submitted to the 
Government.


Anticipated Cost and Benefits:


The Department of Homeland Security had considered the costs and 
benefits in the interim final rule. The interim rule affects entities 
in the private sector that have critical infrastructure information 
that they wish to share

[[Page 72751]]

with DHS. The interim rule requires that when DHS receives, validates, 
and shares CII, DHS and the receiving parties, whether they be other 
Federal agencies or State or local governments with whom DHS has signed 
agreements detailing the procedures on how protected CII must be 
safeguarded, must take appropriate action to safeguard its contents and 
to destroy it when it is no longer needed. The interim rule does not 
require the use of safes or enhanced security equipment or the use of a 
crosscut shredder. Rather, the interim rule requires only that an 
affected entity or person restrict disclosure of, and access to, the 
protected information to those with a need to know, and destroy such 
information when it is no longer needed. Under the rule, a locked 
drawer or cabinet is an acceptable means of complying with the 
requirement to secure Protected Critical Infrastructure Information, 
and a normal paper shredder or manual destruction are acceptable means 
of destroying protected CII.


Risks:


This regulatory project will complement other DHS initiatives designed 
to detect, deter, and prevent terrorist attacks.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            68 FR 18524                                    04/15/03
Interim Final Ru69 FR 8073                                     02/20/04
Interim Final Rule Comment Period End                          05/20/04
Final Action                                                   06/00/05
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


Federal


Federalism:


 This action may have federalism implications as defined in EO 13132.


Agency Contact:
Raghav Kotval
Department of Homeland Security
Washington, DC 20528
Phone: 202 772-5025
RIN: 1601-AA14
_______________________________________________________________________



DHS--OS



70. REGULATIONS IMPLEMENTING THE SUPPORT ANTITERRORISM BY FOSTERING 
EFFECTIVE TECHNOLOGIES ACT OF 2002 (THE SAFETY ACT)
Priority:


Other Significant. Major status under 5 USC 801 is undetermined.


Legal Authority:


Not Yet Determined


CFR Citation:


6 CFR 25


Legal Deadline:


None


Abstract:


This interim rule implements subtitle G of title VIII of the Homeland 
Security Act of 2002--the Support of Antiterrorism by Fostering 
Effective Technologies Act of 2002 (the SAFETY Act). As discussed in 
the SAFETY Act, through regulations promulgated by the Department of 
Homeland Security (the Department), it provides critical incentives for 
the development and deployment of antiterrorism technologies by 
providing liability protections for sellers of ``qualified 
antiterrorism technologies'' and others.


Statement of Need:


This regulation implements the SAFETY Act. The Department believes the 
current development of antiterrorism technologies has been slowed due 
to the potential liability risks associated with their development and 
eventual deployment. In a fully functioning insurance market, 
technology developers would be able to insure themselves against 
excessive liability risk; however, the terrorism risk insurance market 
appears to be in disequilibrium. The attacks of September 11 
fundamentally changed the landscape of terrorism insurance. Congress, 
in the findings of the Terrorism Risk Insurance Act of 2003 (TRIA), 
concluded that temporary financial assistance in the insurance market 
is needed to ``allow for a transitional period for the private markets 
to stabilize, resume pricing of such insurance, and build capacity to 
absorb any future losses.'' TRIA section 101(b)(2). This interim 
rulemaking addresses a similar concern, to the extent that potential 
technology developers are unable to efficiently insure against large 
losses due to an ongoing reassessment of terrorism issues in insurance 
markets.


Even after a temporary insurance market adjustment, purely private 
terrorism risk insurance markets may exhibit negative externalities. 
Because the risk pool of any single insurer may not be large enough to 
efficiently spread and therefore insure against the risk of damages 
from a terrorist attack, and because the potential for excessive 
liability may render any terrorism insurance prohibitively expensive, 
society may suffer from less than optimal technological protection 
against terrorist attacks. The measures set forth in the interim rule 
are designed to meet this goal; they provide certain liability 
protection from lawsuits and consequently will increase the likelihood 
that businesses will pursue important technologies that may not be 
pursued without this protection.


Summary of Legal Basis:


On July 11, 2003, a notice of proposed rulemaking was published 
entitled ``Regulations Implementing the Support Antiterrorism by 
Fostering Effective Technologies Act of 2002 (the SAFETY Act)'' in the 
Federal Register (68 FR 41420). No public hearing was requested and 
none was held. The interim rule was published in October 2003. The 
Department finds that the need to foster antiterrorism technology by 
instituting liability protection measures, as soon as found 
practicable, furnishes good cause for this interim rule to take effect 
immediately under both the Administrative Procedure Act, 5 U.S.C. 
552(d)(3), and section 808 of the Congressional Review Act. The 
Department believes the current development of antiterrorism 
technologies has been slowed due to the potential liability risks 
associated with their development and eventual deployment. In a fully 
functioning insurance market, technology developers would be able to 
insure themselves against excessive liability risk; however, the 
terrorism risk insurance market appears to be in disequilibrium. The 
attacks of September 11 fundamentally changed the landscape of 
terrorism insurance. Congress, in its statement of findings and purpose 
in TRIA, concluded that temporary financial assistance in the insurance 
market is needed to ``allow for a transitional period for the private 
markets to stabilize, resume pricing of such insurance, and build 
capacity to absorb any future losses.'' TRIA section 101(b)(2).


Alternatives:


The Department considered public comments received on the interim rule

[[Page 72752]]

and will determine whether possible supplemental regulations are needed 
as we gain experience with implementing the Act.


Anticipated Cost and Benefits:


Costs and Benefits to Technology Development Firms


Since the interim rulemaking puts in place an additional voluntary 
option for technology developers, the expected direct net benefits to 
firms of the interim rulemaking will be positive; companies presumably 
will not choose to pursue the designation of ``antiterrorism 
technology'' unless they believe it to be a profitable endeavor. The 
Department cannot predict with certainty the number of applicants for 
this program. An additional source of uncertainty is the reaction of 
the insurance market to this designation. As mentioned above, insurance 
markets appear currently to be adjusting their strategy for terrorism 
risk, so little market information exists that would inform this 
estimate. The Department invited comments on these issues.


If a firm chooses to invest effort in pursuing SAFETY Act liability 
protection, the direct costs to that firm will be the time and money 
required to submit the required paperwork and other information to the 
Department. Only companies that choose to request this protection will 
incur costs. Please see the accompanying PRA analysis for an estimate 
of these costs.


The direct benefits to firms include lower potential losses from 
liability for terrorist attacks, and as a consequence a lower burden 
from liability insurance for this type of technology. In this 
assessment, we were careful to only consider benefits and costs 
specifically due to the implementation of the interim rule and not 
costs that would have been incurred by companies absent any interim 
rulemaking. The SAFETY Act requires the sellers of the technology to 
obtain liability insurance ``of such types and in such amounts'' 
certified by the Secretary. The entire cost of insurance is not a cost 
specifically imposed by the interim rulemaking, as companies in the 
course of good business practice routinely purchase insurance absent 
Federal requirements to do so. Any difference in the amount or price of 
insurance purchased as a result of the SAFETY Act would be a cost or 
benefit of this interim rule for firms.


The wording of the SAFETY Act clearly states that sellers are not 
required to obtain liability insurance beyond the maximum amount of 
liability insurance reasonably available from private liability sources 
on the world market at prices and terms that will not unreasonably 
distort the sales price of the seller's antiterrorism technologies. We 
tentatively concluded, however, that this interim rulemaking will 
impact both the prices and terms of liability insurance relative to the 
amount of insurance coverage absent the SAFETY Act. The probable effect 
of the interim rule is to lower the quantity of liability coverage 
needed in order for a firm to protect itself from terrorism liability 
risks, which would be considered a benefit of this interim rule to 
firms. The change will most likely be a shift back in demand that leads 
to a movement along the supply curve for technology firms already in 
this market; they probably will buy less liability coverage. This will 
have the effect of lowering the price per unit of coverage in this 
market.


The Department also expects, however, that the interim rulemaking will 
lead to greater market entry, which will generate surplus for both 
technology firms and insurers. Again, this market is still in 
development, and the Department solicits comments on exactly how to 
predict the effect of this interim rulemaking on technology 
development.


Costs and Benefits to Insurers


The Department has little information on the future structure of the 
terrorism risk insurance market, and how this interim rulemaking 
affects that structure we continue to consider this matter. As stated 
above, this type of intervention could serve to lower the demand for 
insurance in the current market, thus the static effect on the 
profitability of insurers is negative. The benefits of the lower 
insurance burden to technology firms would be considered a cost to 
insurers; the static changes to insurance coverage would cause a 
transfer from insurers to technology firms. On the other hand, this 
type of intervention should serve to increase the surplus of insurers 
by making some types of insurance products possible that would have 
been prohibitive to customers or impossible for insurers to design in 
the absence of this interim rulemaking.


Costs and Benefits to the Public


The benefits to the public of the interim rulemaking were very 
difficult to put in dollar value terms since its ultimate objective is 
the development of new technologies that will help prevent or limit the 
damage from terrorist attacks. It is not possible to even determine 
whether these technologies could help prevent large or small scale 
attacks, as the SAFETY Act applies to a vast range of technologies, 
including products, services, software, and other forms of intellectual 
property that could have a widespread impact. In qualitative terms, the 
SAFETY Act removes a great deal of the risk and uncertainty associated 
with product liability and in the process creates a powerful incentive 
that will help fuel the development of critically needed antiterrorism 
technologies. Additionally, we expect the SAFETY Act to reduce the 
research and development costs of these technologies.


The tradeoff, however, may be that a greater number of technologies may 
be developed and qualify for this program that have a lower average 
effectiveness against terrorist attacks than technologies currently on 
the market, or technologies that would be developed in the absence of 
the interim rulemaking. In the absence of this rulemaking, strong 
liability discouragement implies that the fewer products that are 
deployed in support of antiterrorist efforts may be especially 
effective, since profit maximizing firms will always choose to develop 
the technologies with the highest demand first. It is the tentative 
conclusion of the Department that liability discouragement in this 
market is too strong or prohibitive, for the reasons mentioned above. 
The Department tentatively concludes that this interim rule will have 
positive net benefits to the public, since it serves to strike a better 
balance between consumer protection and technological development. The 
Department welcomes comments informing this tradeoff argument, and 
public input on whether this interim rulemaking does strike the correct 
balance.


Risks:


The United States remains at risk to terrorist attacks. It is in the 
public's interest to have this interim rule effective immediately 
because its aim is to foster the development and deployment of 
antiterrorism technologies. Additionally, this interim rule will 
clarify to the greatest extent possible the application of the 
liability protections created by the SAFETY Act, thus providing an 
instant incentive for prospective applicants to apply for its 
protections and for others to begin exploring new measures that will 
prevent or reduce acts of terrorism. The interim rule will also provide 
the Department with sufficient program

[[Page 72753]]

flexibility to address the specific circumstances of each particular 
request for SAFETY Act coverage. The application process is 
interactive. Those persons availing themselves of the protections 
afforded in this interim rule will also be interacting with the 
Department in the application process. Furthermore, the Department will 
continue to consider comments on this interim rule. Since the use of 
the liability protections afforded in this interim rulemaking is 
voluntary, there are no mandatory costs or burdens associated with the 
immediate implementation of this rule.


By having these provisions in place, the Department may begin 
processing applications for the liability protections and thus provide 
qualified sellers of antiterrorism technologies valuable incentives to 
develop and sell such technologies, as well as incentives for others to 
deploy such technologies. The purpose of those technologies is to 
detect, deter, mitigate, or assist in the recovery from a catastrophic 
act of terrorism. Thus, the Department finds that it is not only 
impracticable to delay an effective date of implementation, but it is 
also in the public's interest to make the interim rule effective upon 
publication in the Federal Register.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            68 FR 41419                                    07/11/03
NPRM Comment Period End                                        08/11/03
Interim Final Ru68 FR 59683                                    10/16/03
Interim Final Rule Comment Period End                          12/15/03
Final Action                                                   12/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal


Agency Contact:
Wendy Howe
Directorate of Science and Technology
Department of Homeland Security
Office of the Secretary
Washington, DC 20528
Phone: 703 575-4511
RIN: 1601-AA15
_______________________________________________________________________



DHS--OS



71. DEPARTMENT OF HOMELAND SECURITY (DHS) HUMAN RESOURCES MANAGEMENT 
SYSTEM
Priority:


Other Significant. Major status under 5 USC 801 is undetermined.


Legal Authority:


PL 107-296, Homeland Security Act


CFR Citation:


5 CFR 970


Legal Deadline:


None


Abstract:


The Department of Homeland Security and the Office of Personnel 
Management are issuing final regulations to establish a new human 
resources management system within DHS, as authorized by the Homeland 
Security Act of 2002. The affected subsystems include those governing 
basic pay, classification, performance management, labor relations, 
adverse actions, and employee appeals. These changes are designed to 
ensure the Department's human resources management system aligns with 
its critical mission requirements without compromising the statutorily 
protected civil service rights of its employees.


Statement of Need:


DHS and OPM have determined that the Department needs to establish a 
new human resources management system, one that is flexible and 
contemporary. The system is being designed to assure that the 
Department will be able to attract, retain, and reward a workforce that 
is able to meet the critical mission entrusted to the Department.


Summary of Legal Basis:


This rule is authorized by the Homeland Security Act of 2002, Public 
Law 107-296--specifically, 5 U.S.C. 9701(a).


Alternatives:


DHS and OPM could have elected not to change the current human 
resources management system. However, the current system does not 
satisfy the needs of the Department. For example, the current system 
rewards longevity of service, requires time-consuming bargaining 
procedures that could detract from the Department's ability to act 
expeditiously to enhance security, and results in lengthy delays for 
resolving issues relating to individual employees.


Within the framework of the new regulations, OM and DHS have considered 
many alternatives to specific regulatory requirements that were 
suggested by employee representatives and individuals who commented on 
the proposed rule and participated in the rulemaking process. An 
analysis of each alternative considered appears in the preamble to the 
regulation.


Anticipated Cost and Benefits:


DHS estimates that the overall costs associated with implementing the 
new DHS HR system will be approximately $130 million through fiscal 
year 2007. Costs will not equal or exceed $100 million in any one year.


Risks:


This description should include, if applicable, ``how the magnitude of 
the risk addressed by the action relates to other risks within the 
jurisdiction of the agency'' (section 4(c)(1)(D) of E.O. 12866). The 
risk addressed is that the Department will be hampered in its efforts 
to implement needed security measures because, for example, it will not 
be able to attract and retain high-performing individuals or will not 
be able to take actions expeditiously. DHS is unable to quantify this 
risk or the extent to which the regulation will reduce it; however, it 
appears likely that the rule will contribute significantly to enhancing 
homeland security.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            69 FR 8030                                     02/20/04
Final Action                                                   12/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal


Agency Contact:
Kay Frances Dolan
Department of Homeland Security
1201 New York Avenue NW.
Washington, DC 20528
Phone: 202 357-8202
Fax: 202 357-8295
Email: [email protected]
Related RIN: Related to 3206-AK31
RIN: 1601-AA21

[[Page 72754]]

_______________________________________________________________________



DHS--U.S. Coast Guard (USCG)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




72. COMMERCIAL FISHING INDUSTRY VESSELS (USCG-2003-16158)
Priority:


Other Significant. Major status under 5 USC 801 is undetermined.


Legal Authority:


46 USC 4502(a) to 4502(d)


CFR Citation:


46 CFR 28


Legal Deadline:


None


Abstract:


This rulemaking would add new and clarify existing rules for commercial 
fishing vessels in 46 CFR part 28. It would also establish rules on 
stability and watertight integrity for fishing vessels under 79 feet in 
length and institute regulations for the carriage of immersion suits in 
seasonally cold waters. To improve crew preparedness in case of an 
emergency, this project would also add requirements such as mandatory 
logging of already required drills, providing evidence of training, and 
ensuring that personnel required to be trained are current in their 
training. The project would amend 46 CFR part 28 to clarify and improve 
the consistency of the regulatory language so to aid in vessels 
compliance with the existing rules. This rulemaking supports the Coast 
Guard's strategic goals of maritime safety and protection of natural 
resources.


Statement of Need:


Commercial fishing remains one of the most dangerous industries in 
America. The Commercial Fishing Industry Vessel Safety Act of 1988 (the 
Act, codified in 46 U.S.C., chapter 45) mandated regulations intended 
to improve the safety of vessels operating in that industry. The Coast 
Guard first issued rules under the Act in 1991. This rulemaking would 
complete our earlier, incomplete efforts to require fishing vessels to 
carry immersion suits for their workers and to incorporate stability 
features in their design. We would also require vessels to document 
certain training and drill measures, require the use of high water 
alarms in some spaces, and revise or clarify some existing 
requirements, all to reflect industry and Coast Guard experience since 
passage of the Act.


Summary of Legal Basis:


46 U.S.C. 4502, as delegated by the Secretary of DHS to the Coast 
Guard.


Alternatives:


Regulatory alternatives considered and rejected: (a) maintain 
regulatory status quo; (b) full Coast Guard licensing of commercial 
fishermen and full Coast Guard inspection of commercial fishing; (c) 
adopt training-based certificate program for operators and crew. 
Nonregulatory alternatives considered: continue voluntary compliance 
with Coast Guard 1986 guidelines.


Anticipated Cost and Benefits:


The bulk of the costs are expected to come from the stability and 
watertight integrity requirements as well as the requirement for 
carrying immersion suits in seasonally cold waters. Exempting existing 
vessels from the stability and watertight regulations would reduce the 
costs considerably. The benefits of this rule would be calculated by 
isolating the specific marine-casualty cases over a suitable time that 
could have been prevented or mitigated by the rule. Cases will be 
retrieved from a Coast Guard database. After each casualty has been 
looked at individually to establish a causal link between the 
regulation in question and the correlating benefit, damages to vessels, 
lives lost, and injuries will be quantified and given dollar values.


Risks:


Commercial fishing continues to rank at or near the top of the most 
hazardous occupations in the United States. Coast Guard data indicate 
that regulations adopted under the 1988 Act have had a significant 
impact in reducing industry casualties, but that impact has leveled 
off. Studies suggest that this rulemaking, by targeting significant 
remaining problem areas, could have an additional significant impact on 
casualty reduction.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           07/00/05
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


Federal, Tribal


Agency Contact:
Lt. Kenneth Vazquez
Project Manager, G-MOC-3
Department of Homeland Security
U.S. Coast Guard
2100 Second Street SW.
Washington, DC 20593
Phone: 202 267-0478
RIN: 1625-AA77
_______________________________________________________________________



DHS--USCG

                              -----------

                            FINAL RULE STAGE

                              -----------




73. POST CASUALTY DRUG AND ALCOHOL TESTING (USCG-2001-8773)
Priority:


Other Significant


Legal Authority:


PL 105-383, sec 304


CFR Citation:


46 CFR 4


Legal Deadline:


None


Abstract:


This project will revise the requirements for chemical testing 
following a serious marine incident. The revision will establish 
procedures to ensure that alcohol testing be conducted within two hours 
of a serious marine incident, as required by the Coast Guard 
Authorization Act of 1998. The rule will also make additional minor 
procedural changes to the part. This rule supports the Coast Guard 
strategic goal of maritime safety.


Statement of Need:


The Coast Guard proposes changing the alcohol testing requirements for 
commercial vessels following a serious marine incident. The 1998 Coast 
Guard Authorization Act requires the Coast Guard to establish 
procedures ensuring alcohol testing is conducted within two hours of a 
serious marine casualty. The Coast Guard proposes to establish 
requirements for testing within the statutory time limits, to expand 
the existing requirements for commercial vessels to have alcohol-
testing devices on board, and to authorize use of a wider variety of 
testing devices. This rulemaking would also make additional minor 
procedural changes to part 4, including a time limit for conducting 
drug testing following a serious marine incident. This action is 
required to

[[Page 72755]]

comply with the 1998 Coast Guard Authorization Act.


Summary of Legal Basis:


In 1998, Congress passed Public Law 105-383, which revised title 46, 
U.S. Code, by adding a new section 2303a, Post Serious Marine Casualty 
Alcohol Testing (hereafter section 2303a). Section 2303a requires the 
Coast Guard to establish procedures ensuring that after a serious 
marine casualty occurs, required alcohol testing is conducted no later 
than two hours after the casualty occurred. If the alcohol testing 
cannot be conducted within that timeframe because of safety concerns 
directly related to the casualty, section 2303a requires the alcohol 
testing to be conducted as soon thereafter as the safety concerns have 
been adequately addressed to permit such testing. However, section 
2303a prohibits us from requiring alcohol testing to be conducted more 
than eight hours after the casualty occurs.


Alternatives:


We would use the standard rulemaking process to develop regulations for 
serious marine incident alcohol testing. Nonregulatory alternatives 
such as Navigation and Vessel Inspection Circulars and Marine Safety 
Manual have been considered and may be used for the development of 
policy and directives to provide the maritime industry and our field 
offices guidelines for implementation of the regulation. Nonregulatory 
alternatives cannot be substituted for the standards being proposed 
with this rule.


Anticipated Cost and Benefits:


A cost analysis was prepared and published with the notice of proposed 
rulemaking on February 28, 2003 (67 FR 9622). The benefits of this 
action will be to ensure that alcohol tests are conducted after serious 
marine incidents so that the public will be informed whether or not 
alcohol use contributed to the incident. This action will also deter 
improper alcohol use by commercial vessel personnel.


Risks:


Under current regulations, the risk of not obtaining a valid alcohol 
test after a serious marine incident is high because specific time 
frames are not given. This action will significantly reduce the risk of 
not obtaining a valid test.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            68 FR 9622                                     02/28/03
NPRM Comment Period End                                        06/30/03
Notice of Public68 FR 50992eopening of Comment Period          08/25/03
NPRM; Reopening 68 FR 60073Period                              10/21/03
Comment Period End                                             11/20/03
Final Rule                                                     04/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses, Governmental Jurisdictions


Government Levels Affected:


Local, State


Additional Information:


Transferred from RIN 2115-AG07


URL For More Information:
dms.dot.gov
URL For Public Comments:
dms.dot.gov
Agency Contact:
Robert C. Schoening
Project Manager, G-MOA-1
Department of Homeland Security
U.S. Coast Guard
2100 Second Street SW.
Room 2406
2100 Second Street SW.
Washington, DC 20593-0001
Phone: 202 267-0684
Email: [email protected]
RIN: 1625-AA27
_______________________________________________________________________



DHS--Directorate of Border and Transportation Security (BTS)

                              -----------

                            FINAL RULE STAGE

                              -----------




74.  UNITED STATES VISITOR AND IMMIGRANT STATUS INDICATOR 
TECHNOLOGY PROGRAM (US-VISIT); AUTH. TO COLLECT BIOMETRIC DATA FROM 
ADDIT'L TRAVELERS AND EXPANSION TO 50 MOST HIGHLY TRAFFICKED LAND 
BORDER PORTS
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


8 USC 1365a; . . .


CFR Citation:


8 CFR 215; 8 CFR 235; 8 CFR 252


Legal Deadline:


Other, Statutory, September 30, 2004, Publication deadline to meet 
representations made to Congress.


Abstract:


This interim rule was signed by the Secretary on August 26, 2004, and 
published in the Federal Register on August 31, 2004. This interim rule 
expands US-VISIT to the 50 most highly trafficked land border ports of 
entry in the United States. This interim rule also will require persons 
entering the United States without visas under the Visa Waiver Program 
(VWP) to provide biometric, biographic, and other information required 
under US-VISIT.


Statement of Need:


On January 5, 2004, the Department established the United States 
Visitor and Immigrant Status Technology Program (US-VISIT), an 
integrated, automated entry-exit system that records the arrival and 
departure of aliens; verifies aliens' identities; and authenticates 
aliens' travel documents through comparison of biometric identifiers. 
The US-VISIT Program is integral to strengthening the security of the 
United States. US-VISIT requires aliens seeking to be admitted to the 
United States pursuant to nonimmigrant visas to provide fingerprints, 
photographs, or other biometric identifiers upon arrival in, or 
departure from, the United States at designated ports of entry and 
departure.


This interim rule is necessary to safeguard the public safety by 
expanding the US-VISIT program to the 50 most highly trafficked land 
border ports of entry in the United States. Further, this interim rule 
authorizes the Department to obtain biometric information from persons 
traveling without visas under the VWP. Enrolling VWP travelers in US-
VISIT will allow the Department to conduct biometric-based checks at 
time of a VWP traveler's application for admission into the United 
States and thus greatly reduces the risk that the VWP traveler's 
identity could subsequently be used by another traveler seeking to 
enter the United States.


Summary of Legal Basis:


The Department established US-VISIT in accordance with several 
statutory mandates that collectively require the Department to create 
an integrated, automated entry and exit system (entry-exit system) that 
records the arrival and departure of aliens; verifies the

[[Page 72756]]

identities of aliens; and authenticates travel documents presented by 
such aliens through the comparison of biometric identifiers. Aliens 
subject to US-VISIT requirements may be required to provide 
fingerprints, photographs, or other biometric identifiers upon arrival 
in, or departure from, the United States. The statutory mandates which 
authorize the Department to establish US-VISIT include, but are not 
limited to, section 2(a) of the Immigration and Naturalization Service 
Data Management Improvement Act of 2000 (DMIA), Public Law 106-215; 
section 205 of the Visa Waiver Permanent Program Act of 2000 (VWPPA), 
Public Law 106-396; section 414 of the Uniting and Strengthening 
America by Providing Appropriate Tools Required to Intercept and 
Obstruct Terrorism Act of 2001 (USA PATRIOT Act), Public Law 107-56; 
and section 302 of the Enhanced Border Security and Visa Entry Reform 
Act of 2002 (Border Security Act) Public Law 107-173.


Under DMIA (8 U.S.C. section 1365a(d)), the Department is required to 
implement US-VISIT at the 50 most highly trafficked land border ports 
of entry no later than December 31, 2004. This interim rule allows the 
Department to meet that statutory deadline.


Alternatives:


The Department will continue to consider public comments and determine 
whether possible supplemental regulations are needed as we gain 
experience with implementing this program.


Anticipated Cost and Benefits:


The anticipated benefits of this rule include: (1) improving 
identification of travelers who may present threats to public safety 
and the national security of the United States through use of biometric 
identifiers; (2) enhancing the government's ability to match an alien's 
fingerprints and photographs to other law enforcement or intelligence 
data associated with identical biometrics; (3) improving the ability of 
the United States to identify individuals who may be inadmissible to 
the United States; (4) improving cooperation across international, 
Federal, State, and local agencies through better access to data on 
foreign nationals who may pose a threat to the United States; (5) 
improving facilitation of legitimate travel and commerce by improving 
the timeliness and accuracy of the determination of a traveler's 
immigration status and admissibility; (6) enhancing enforcement of 
immigration laws, contributing to the increased integrity of the system 
of immigration in the United States, including the collection of more 
complete arrival and departure information on VWP travelers and aliens 
who seek to enter the United States through a land border port of 
entry; (7) reducing fraud, undetected impostors, and identity theft; 
and, (8) increasing integrity within the VWP program, through better 
data collection, tracking, and identification, allowing better 
compliance monitoring through increased and more accurate data.


The costs associated with implementation of this interim rule for 
travelers not otherwise exempt from US-VISIT requirements include an 
increase of approximately 15 seconds in inspection processing time per 
applicant over the current average inspection time of one minute, 
whether at a land, air, or sea port-of-entry. No significant difference 
is anticipated in the processing of an alien traveling with a visa as 
compared to a traveler without a visa under VWP.


The Department anticipates that, by December 31, 2005, when US-VISIT is 
required to be implemed at all land border ports of entry in the United 
States, approximately 3.2 million nonimmigrant applicants for Form I-94 
issuance could be affected at the designated land ports-of-entry. The 
Department, when conducting a cost-benefit analysis for the January 5, 
2004, interim rule, estimated that the time required to obtain the 
biometric information required under US-VISIT was approximately 15 
seconds per person. Since the implementation of US-VISIT at air and sea 
ports on January 5, 2004, the Department has not received reports of 
average processing times greater than 15 seconds nor any significant 
delays for travelers resulting from the collection of biometric 
information under US-VISIT. The limited 15 second processing time was 
not expected to cause significant delays for travelers at air or sea 
ports because persons not required to provide biometrics (e.g. U.S. 
citizens, lawful permanent residents, and visa-exempt non-immigrants) 
generally are routed through different inspection lines, thereby easing 
any impact of the biometric collection process. Because the same 
biometric information will be obtained at land border ports of entry, 
through a similar secondary inspection process, DHS does not anticipate 
any increase in the 15 second processing time or any significant delay 
for travelers at land border ports of entry in the United Stated.


In addition, over time, the efficiency with which the process is 
employed will increase, and the process can be expected to improve 
further.


The additional costs to the Government and the public to implement the 
requirements of this rule are approximately $155 million for all 50 
ports during fiscal year 2004, or approximately $3.1 million at each of 
the ports. These expenditures are required to upgrade the information 
technology hardware (i.e. desktop hardware and peripherals, upgrading 
local and wide area networks) at the affected ports.


Risks:


The United States remains at risk to terrorist attacks. Since its 
implementation in January 2004, US-VISIT has proven that the use of 
biometrics to check identity and background is a highly effective law 
enforcement tool. US-VISIT has already prevented 196 criminal aliens 
from entering the United States, even though the program is currently 
operating on a limited basis. Expanding the classes of aliens subject 
to US-VISIT to VWP aliens immediately should result in additional 
aliens being identified on ``lookout'' lists being prevented admission 
or arrested as fugitives or wanted criminals. Further, expanding the 
program to include the major land border ports-of-entry should result 
in even more ``hits.'' Accordingly, expanding both the classes of 
aliens subject to US-VISIT, as well as the location of ports where US-
VISIT will be implemented, will have a considerable and positive effect 
on national security. Any delay in the implementation of this interim 
rule to allow for public comment may increase the opportunity for 
aliens who may otherwise not be admissible to the United States, due to 
suspected terrorist affiliations or criminal records, to enter the 
United States using false identifies, and false, fraudulent, or stolen 
passports or other travel documents.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Interim Final Ru69 FR 53318                                    08/31/04
Interim Final Rule Effective                                   09/30/04
Final Action                                                   12/00/04
Regulatory Flexibility Analysis Required:


No

[[Page 72757]]

Small Entities Affected:


No


Government Levels Affected:


Federal


Public Compliance Cost:
; Yearly Recurring Cost: $155000000; Base Year for Dollar Estimates: 
2004
Agency Contact:
Michael Hardin
Department of Homeland Security
Directorate of Border and Transportation Security
US-VISIT
18th floor
1616 N. Fort Myer Drive
Arlington, VA 22209
Phone: 202 298-5200
Email: [email protected]
Related RIN: Related to 1651-AA54
RIN: 1650-AA00
_______________________________________________________________________



DHS--Bureau of Immigration and Customs Enforcement (BICE)

                              -----------

                             PRERULE STAGE

                              -----------




75.  ESTABLISHING PROCEDURES FOR RECERTIFICATION OF SCHOOLS 
APPROVED BY THE STUDENT AND EXCHANGE VISITOR PROGRAM (SEVP) TO ENROLL F 
OR M NONIMMIGRANT STUDENTS
Priority:


Other Significant


Legal Authority:


PL 107-173, sec 502; 8 USC 1356(m); PL 107-56


CFR Citation:


8 CFR 103; 8 CFR 214


Legal Deadline:


Final, Statutory, October 2004, Schools become eligible for 
recertification as early as October 1, 2004.


The Uniting and Strengthening America by Providing Appropriate Controls 
Required to Intercept and Obstruct Terrorism Act (USA PARTRIOT Act), 
Public Law 107-56, mandated that SEVIS be completely implemented before 
January 1, 2003. Both Directive No. 2 and the Border Security Act 
require DHS to conduct periodic reviews of all schools within two years 
of the initial approval of their SEVP certification, and every two 
years thereafter. In order to meet this mandate.


Abstract:


This interim rule amends DHS regulations governing recertification of 
schools approved by the Student and Exchange Visitor Program (SEVP) for 
attendance by F or M nonimmigrant students. It sets the fee amount for 
recertification at a flat nonrefundable rate of $580 dollars, adds a 
provision to allow a school to voluntarily withdraw from its 
certification, and clarifies procedures for school operation with 
regard to nonimmigrant students during the review process and following 
withdrawal of certification.


On October 30, 2001, the President issued Homeland Security Directive 
No. 2, requiring periodic reviews of all institutions certified to 
receive nonimmigrant students. The Enhanced Border Security and Visa 
Entry Reform Act of 2002 (Border Security Act), Public Law 107-173, 
enacted May 14, 2002, also requires a periodic review of approved 
schools every two years. This rule is being promulgated consistent with 
these mandates.


Statement of Need:


The Uniting and Strengthening America by Providing Appropriate Tools 
Required to Intercept and Obstruct Terrorism Act (USA PATRIOT Act), 
Public Law 107-56, mandated that SEVIS be fully implemented prior to 
January 1, 2003. Both Directive 2, and the Border Security Act require 
DHS to conduct periodic reviews of all schools within two years of 
their initial SEVP certification and every two years thereafter. In 
order to meet this mandate and because the periodic review of all 
approved schools is important to safeguarding against abuse of American 
openness to foreign students by foreign terrorists, this rule must be 
effective immediately. Vital national security concerns that underpin 
Directive No. 2, the USA PATRIOT Act, and the Border Security Act might 
be placed at risk by observing the requirements of 5 U.S.C. 533(b) and 
(d). Additionally, the provision for the recertification fee has been 
in 8 CFR 124.3(h)(3) since September 25, 2002.


Summary of Legal Basis:


On October 30, 2001, the President issued Homeland Security Directive 
No. 2 (Directive 2) requiring DHS to conduct periodic reviews of all 
institutions approved to accept nonimmigrant students. More recently, 
section 502 of the Enhanced Border Security and Visa Entry Reform Act 
of 2002 (Border Security Act), Public Law 107-173, enacted May 14, 
2002, required DHS to review all schools approved for attendance by F 
or M nonimmigrant students within two years of the passage of the 
Border Security Act. Further, it mandates that DHS recertify the 
approval of all schools every two years thereafter. 8 U.S.C. 1356(m) 
requires the recovery of the full cost of providing adjudication 
services for immigration-related benefits. Because certification allows 
schools to have their foreign students admitted to the United States as 
nonimmigrants under certain visa categories, certification constitutes 
a benefit under title 8 and is subject to the 1356(m) requirement. The 
requirement for recertification and the intent to charge a fee was 
established in 67 FR 60107 (September 25, 2002). At that time, it was 
anticipated that the cost of recertification would be comparable to the 
cost of initial certification.


Alternatives:


None


Anticipated Cost and Benefits:


8 U.S.C. 1356(m) requires the recovery of the full cost of providing 
adjudication services for immigration-related benefits. Because 
certification allows schools to have their foreign students admitted to 
the United States as nonimmigrants under certain visa categories, 
certification constitutes a benefit under title 8 and is subject to the 
1356(m) requirement.


The requirement for recertification and the intent to charge a fee was 
established in 67 FR 60107 (September 25, 2002). At that time, it was 
anticipated that the cost of recertification would be comparable to the 
cost of initial certification.


Combined with a fee collected from nonimmigrant F and M students and J 
exchange visitors, the fees in this rule are intended to meet costs of 
SEVP.


Risks:


Timely implementation of this rule is critical to continued fulfillment 
of the SEVP mission.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM                                                          01/00/05
NPRM                                                           06/00/05
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses, Organizations

[[Page 72758]]

Government Levels Affected:


None


Additional Information:


ICE No. 2329-04


Agency Contact:
Susan Geary
Acting Director, Student and Visitor Exchange Program
Department of Homeland Security
Bureau of Immigration and Customs Enforcement
800 K Street NW.
Washington, DC 20536
Phone: 202 305-2346
Fax: 202 353 3723
Email: [email protected]
RIN: 1653-AA42
BILLING CODE 4410-10-S

[[Page 72759]]




DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT (HUD)



Statement of Regulatory Priorities
 The regulatory plan for the Department of Housing and Urban 
Development for fiscal year (FY) 2005 highlights the priority 
regulations and policy initiatives directed toward the achievement of 
HUD's traditional goals of increasing the supply of affordable housing 
(rental and homeownership), ensuring equal opportunity for housing, and 
promoting jobs and economic development, as well as its more recent 
goal of restoring the public's trust in HUD. These goals are embodied 
in HUD's mission and its strategic goals for FY 2005.
 Under the leadership of Secretary Alphonso Jackson, HUD approaches the 
new fiscal year with a renewed sense of commitment to its mission and 
goals and greater accountability for its performance. Reflecting HUD's 
role as the primary Federal agency responsible for addressing America's 
housing needs and improving and developing the nation's communities, 
the Secretary's regulatory plan is designed to implement HUD's broad, 
but focused, strategic goals and objectives. HUD's strategic goals and 
objectives are to:
1. Increase homeownership opportunities;
2. Promote decent, affordable housing;
3. Strengthen communities;
4. Ensure equal opportunity in housing;
5. Embrace high standards of ethics, management, and accountability; 
            and
6. Promote participation of faith-based and community organizations.
 Under the leadership of Secretary Jackson, HUD's regulatory plan for 
FY 2005 builds upon the successes of the previous fiscal year through 
regulations that are designed to expand homeownership opportunities, 
promote decent, affordable housing, particularly for the most 
vulnerable Americans, and strengthen America's communities.
Priority: Expanding Homeownership through Educating Potential First-
time Homebuyers
 Helping more low- and moderate-income Americans become homeowners is a 
national priority. Under the leadership of Secretary Jackson, the 
Department is committed to helping everyone, especially first-time 
homebuyers and minority families, take advantage of new opportunities 
to own their own homes. The reasons for this priority are clear. 
Homeownership benefits individual families by helping them build 
economic security, and it fosters healthy, vibrant communities. Owning 
a home is good for families and provides a sense of security that 
allows families to build wealth. Homeownership is also good for 
communities. Homeowners work to maintain the value of their investment, 
which translates into a greater concern for neighborhoods and 
surrounding communities. A family that owns its home is more likely to 
upgrade the property, to take pride in its neighborhood, and to feel 
invested in the community. When citizens become homeowners, they become 
stakeholders as well. By increasing the ranks of stakeholders, 
communities not only enjoy increased stability, but also benefit from a 
new spirit of revitalization.
Regulatory Action: Housing Counseling
 In order to expand homeownership, the Department is working to ensure 
that those who purchase a home are better able to avoid circumstances 
that might result in foreclosure. An educated homebuyer is the best 
defense against abusive lending practices, known as predatory lending, 
that have too often been used by unscrupulous lenders. One of the best 
ways to avoid future problems and promote homeownership is to educate 
families about the process and responsibilities of homeownership. 
Housing counseling services can also help low- and moderate-income 
renters improve their access to affordable housing by increasing their 
abilities to budget for needed home expenses and regular rent payments, 
enhancing their housing conditions, and helping them to avoid rental 
delinquency. These counseling services have proven to be extremely 
important in helping families purchase a home and keep it in times of 
financial stress. With appropriate advice, families coping with 
financial difficulties are more likely to survive tough times with 
their homes intact. As a result, HUD is pursuing rulemaking to codify 
the key provisions of its housing counseling program. Housing 
counseling services include assisting eligible homebuyers to seek out 
and purchase homes; helping renters locate and qualify for assisted 
rental units; helping eligible homebuyers obtain affordable housing; 
assisting homeowners to avoid foreclosures; assisting renters to avoid 
evictions; helping the homeless find temporary or permanent shelter; 
reporting fair housing or discrimination complaints or both; and 
addressing other housing problems.
Priority: Expanding Homeownership by Helping Existing Homeowners Keep 
Their Homes
 HUD is continuing its efforts to assist first-time homeowners maintain 
their homeownership status. Among the ways HUD is advancing this goal 
is through foreclosure prevention activities and better monitoring of 
appraisals. In particular, the requirement imposed on Federal Housing 
Administration (FHA) lenders to engage in loss mitigation has proven a 
successful strategy for assisting homeowners keep their homes and will 
be strengthened.
 Regulatory Action: Treble Damages For Failure to Engage in Loss 
Mitigation
 The HUD appropriations act for fiscal year 1999 amended the National 
Housing Act (NHA) to add a triple penalty for failure to engage in 
appropriate loss mitigation to the existing civil money penalty system. 
Section 230(a) of title II of the NHA, as amended, makes it mandatory 
for the mortgagee, upon the default of a single-family mortgage, to 
engage in loss mitigation actions, including, but not limited to, 
special forbearance, loan modification, and deeds in lieu of 
foreclosure, for the purpose of providing alternatives to foreclosure. 
On April 14, 2004, HUD published a proposed rule that would amend HUD's 
civil money penalty regulations to reflect HUD's authorization to 
impose treble damages on a mortgagee for any mortgage for which the 
mortgagee had a duty but failed to engage in appropriate loss 
mitigation actions. The proposed rule followed publication of an 
advanced notice of proposed rulemaking (ANPRM) and took into 
consideration public comments on the ANPRM. HUD intends to give 
priority to making this rule final.
Priority: Promote Decent Affordable Housing
 While seeking to expand homeownership opportunities, HUD recognizes 
that homeownership may not be practical for all families. To help these 
families obtain safe, decent, and affordable housing, HUD's regulatory 
plan will strengthen its current rental assistance programs. HUD will 
focus on improving the physical quality of public and assisted housing 
and on improving housing agencies' utilization of assistance.
 Regulatory Action: Public Housing Operating Fund Program

[[Page 72760]]

 On October 21, 1998, the Congress enacted the Quality Housing and Work 
Responsibility Act of 1998 (QHWRA), which made sweeping changes to 
HUD's public and assisted housing programs. Section 519 of QHWRA 
amended section 9 of the United States Housing Act of 1937 to establish 
an operating fund for the purpose of making assistance available to 
public housing agencies (PHAs) for the operation and management of 
public housing. On March 29, 2001, HUD published an interim rule, 
developed through negotiated rulemaking, implementing the operating 
fund.
 Since that time, HUD, as directed by Congress, contracted with the 
Harvard University Graduate School of Design to conduct a study of the 
cost incurred in operating a well run public housing agency (the 
Harvard Cost Study). The Harvard University Graduate School of Design 
performed extensive research on the issue of calculating the expense 
level of well managed public housing and conducted a number of public 
meetings to allow for an exchange of thoughts and expectations with 
PHAs. The Harvard University Graduate School of Design issued its final 
report on June 6, 2003.
 On March 10, 2004, HUD announced the establishment of its Negotiated 
Rulemaking Committee on the Operating Fund. The goal of the committee 
was to provide advice and recommendations for a rule for effectuating 
changes to the Operating Fund Program in response to the Harvard Cost 
Study. The committee held four meetings to complete its work. Operating 
by consensus decisionmaking and under its approved charter and 
protocols, the committee developed a rule, the goal of which is to 
improve and clarify the current regulations governing the Operating 
Fund Program. The rule also takes into consideration the 
recommendations contained in the Harvard Cost Study.
Regulatory Action: Project-Based Voucher Program
 The Project-Based Voucher Program replaces the former Project-Based 
Certificate Program and provides PHAs with flexibility in administering 
the program that will assist PHAs in increasing housing opportunities. 
The Project-Based Program was authorized by law in 1998, as part of the 
statutory merger of the certificate and voucher tenant-based programs. 
In 2000, the Congress substantially revised the project-based voucher 
law. The statutory revisions of 2000 made a number of changes to the 
program including permitting a PHA to pay project-based assistance for 
a term of up to 10 years, permitting a PHA to provide project-based 
assistance for existing housing that does not need rehabilitation, as 
well as for newly constructed or rehabilitated housing, and allowing a 
family to move from a project-based voucher unit after one year and 
transfer to the PHA's tenant-based voucher program. Initial guidance on 
the new law was provided to PHAs and residents in January 2001. On 
March 18, 2004, HUD published a proposed rule that would begin the 
process of providing the more permanent regulatory framework for this 
new program. HUD intends to give priority to making this rule final.
 Regulatory Action: Public Housing Capital Fund Program
 QHWRA also amended section 9 of the United States Housing Act of 1937 
to establish a capital fund for the purpose of making assistance 
available to PHAs for the development, financing, and modernization of 
public housing. This proposed rule would establish the full regulatory 
framework for the capital fund program. This proposed rule would 
combine several legacy programs. Many of the requirements of these 
programs are redundant, overlapping, and in need of updating. In 
addition, new components, such as capital fund financing, capital-fund-
only assistance, and homeownership, need program guidance. HUD is 
embarking on a comprehensive review of the legacy programs to 
streamline, shorten, and combine the requirements into a single 
regulation.
 Regulatory Action: Revisions to Indian Housing Block Grant Program
 HUD's policy to promote the general welfare by meeting the national 
goal of providing decent, safe, and affordable housing extends to the 
nation's over 562 federally recognized Indian tribes. HUD's tribal 
partners are diverse. They are located on Indian reservations, in 
Alaska Native villages, and in other traditional Indian areas. In 
addressing tribal housing issues, HUD is committed to the principle of 
government-to-government relations with federally recognized Indian 
tribes. In this regard, HUD established a negotiated rulemaking 
committee to develop several revisions to the Indian Housing Block 
Grant Program allocation formula authorized under section 302 of the 
Native American Housing Assistance and Self-Determination Act of 1996. 
The first meeting of the committee took place in April 2003. Overall, 
the committee met a total of seven times, with the final meeting held 
in January 2004. Based on the committee's agreement to operate by 
consensus rulemaking and under its approved charter and protocols, the 
committee undertook a comprehensive review of the Indian Housing Block 
Grant (IHBG) formula. The committee identified certain areas of the 
IHBG formula that required clarification, were outdated, or were not 
operating as intended by the original negotiated rulemaking committee. 
This proposed rule reflects the consensus decisions as reached by the 
committee during the negotiated rulemaking process on the best way to 
address these issues.
Priority: Strengthen Communities
 HUD is committed to preserving America's cities as vibrant hubs of 
commerce and making communities better places to live, work, and raise 
a family. Toward this end, many State and local governments depend upon 
HUD and its system of grants to support community development projects, 
revive troubled neighborhoods, and spark urban renewal. HUD is 
committed to helping communities address development priorities through 
local decisionmaking. HUD will also move to ensure that its community 
development partners have greater flexibility to address locally 
determined priorities and maintain long-term prosperity.
 Regulatory Action: Streamlining the Consolidated Plan
 In fiscal year 2002, the President's Management Agenda directed HUD to 
work with local stakeholders to streamline the consolidated plan, 
making it more results-oriented and useful to communities in assessing 
their own progress toward addressing the problems of low-income areas. 
To launch this activity, HUD held several focus group sessions with 
grantees and other stakeholders in 2002 to discuss ways to streamline 
the consolidated plan and improve performance measurement. HUD also 
convened a national planning meeting to introduce the concept of the 
Consolidated Plan Improvement Initiative to a national audience that 
included public interest groups, grantees, and other stakeholders. At 
this meeting, six working groups were established to assess alternative 
planning requirements, review performance measures, and identify 
communities that would be willing to test pilots of alternative 
planning procedures.
 This proposed rule resulted from an extensive consultation process 
that involved stakeholders representing the

[[Page 72761]]

interests of State and local governments and low-income persons. The 
proposed rule builds on the existing framework that established the 
consolidated plan as a collaborative process whereby a community 
establishes a unified plan of community development actions. That 
framework gives States and local governments the flexibility to use 
existing plans and strategies to help citizens understand the 
jurisdiction's priority needs and assess the jurisdiction's progress 
toward meeting identified goals and objectives through measurable 
indicators.
 Regulatory Action: Empowerment Zone Resident Benefit and Economic 
Development
 In December 1998, HUD designated 15 new urban Empowerment Zones (EZs). 
The 1998 designation is referred to as Round II. These designees are 
able to use tax-incentive packages to open new businesses, provide 
thousands of new jobs, rehabilitate and build new housing, and change 
lives for the better in urban and rural areas throughout the Nation. 
This EZ initiative offers communities opportunities and resources to 
overcome seemingly insurmountable problems by providing incentives for 
new business, affordable housing, and jobs. HUD believes that the 
opportunity to prosper through tax incentives is a major shift in the 
paradigm of how government creates the atmosphere to stimulate economic 
revitalization.
 This regulation would ensure that Round II EZs assure that a certain 
level of the benefits resulting from the use of and the expenditure of 
associated grant funds will accrue to persons who reside within the EZ. 
Accordingly, this regulation would require an implementation plan 
submitted for HUD approval by EZs to describe their planned use of HUD 
EZ grants funds to meet one of three standards of resident benefit: a 
principal benefit standard, a proportional benefit standard, or an 
exception criterion for determining the amount of HUD EZ grant funds 
that may be used to fund a particular project or activity described in 
an implementation plan. This rule would also provide more specific 
direction on the restriction contained in the statutory language 
appropriating the funds that the HUD EZ grant funds be used ``in 
conjunction with economic development activities'' and sets standards 
for applying the restriction to individual activities that may be 
assisted through the use of the funds.
The Priority Regulations that Comprise HUD's FY 2005 Regulatory Plan
A more detailed description of the priority regulations that comprise 
HUD's FY 2005 regulatory plan follows.
_______________________________________________________________________



HUD--Office of the Secretary (HUDSEC)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




76. CONSOLIDATED PLAN AMENDMENTS (FR-4923)
Priority:


Other Significant


Legal Authority:


42 USC 3535(d); 42 USC 3601 to 3619; 42 USC 5301 to 5315; 42 USC 12701 
to 12711; 42 USC 12741 to 12756; 42 USC 12901 to 12912; . . .


CFR Citation:


24 CFR 91


Legal Deadline:


None


Abstract:


This rule would amend the consolidated plan regulations to make 
clarifying and streamlining changes that are expected to make the 
consolidated plan more results-oriented and useful to communities in 
assessing their own progress toward addressing the problems of low-
income areas. The proposed rule would eliminate some obsolete and 
redundant provisions and make other changes that would conform the 
consolidated plan regulations with HUD's public housing regulations 
that govern the Public Housing Agency Plan.


Statement of Need:


This rule resulted from an extensive consultation process that involved 
stakeholders representing the interests of State and local governments 
and low-income persons. The general view of the involved stakeholders 
was that the consolidated plan should be a concise, action-oriented 
management tool that would be more understandable to the public and 
more useful to decisionmakers in the community.


Summary of Legal Basis:


The Consolidated Plan incorporates the planning activities of the 
Comprehensive Housing Affordability Strategy (CHAS), enacted by the 
Cranston-Gonzalez National Affordable Housing Act of 1990 and the 
document submission requirements for four formula grant programs: 
Community Development Block Grant, HOME, Emergency Shelter Grant, and 
Housing Opportunities for Persons with AIDS (HOPWA).


Alternatives:


This action is a rule of general applicability and future effect that 
does not fall into any of the rulemaking exceptions.


Anticipated Cost and Benefits:


This rule is based on an extensive consultation process that involved 
numerous stakeholders representing the interests of State and local 
governments and low-income persons. Anticipated changes benefit State 
and local governments by providing a streamlined reporting process that 
is more internally consistent and conforms to recent statutory changes. 
At the same time, this rule should have minimal impact on State and 
local governments.


Risks:


This rule poses no threat to public safety, health, or the environment.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           11/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Salvatore Sclafani
Office of Policy Development and Coordination, Office of Community 
Planning and Development
Department of Housing and Urban Development
Phone: 202 708-1817
RIN: 2501-AD07

[[Page 72762]]

_______________________________________________________________________



HUD--HUDSEC

                              -----------

                            FINAL RULE STAGE

                              -----------




77. TREBLE DAMAGES FOR FAILURE TO ENGAGE IN LOSS MITIGATION (FR-4553)
Priority:


Other Significant


Legal Authority:


12 USC 1715u; 12 USC 1735f-14; 12 USC 1701q-1; 12 USC 1703; 1735f-15; 
15 USC 1717a; 28 USC 2641 note; 12 USC 1709; 12 USC 1710; 12 USC 1715b; 
42 USC 3535(d)


CFR Citation:


24 CFR 30; 24 CFR 203


Legal Deadline:


None


Abstract:


This rule will implement a statutory triple penalty for failure to 
engage in loss mitigation to the existing penalty system, and will also 
describe the process for assessing treble damages when a mortgagee 
fails to engage in loss mitigation activities with cooperative and 
qualified mortgagors. The rule will amend 24 CFR parts 30 and 203 to 
set out the maximum penalty amounts for those servicing mortgagees that 
fail to engage in loss mitigation. Mortgagees that fail to engage in 
loss mitigation may be subject to penalties of three times the amount 
of any mortgage insurance benefits claimed by the mortgagee. In 
assessing loss mitigation performance, this rule will rank mortgagees 
into four tiers, with tier 1 representing the highest loss mitigation 
performance, and tier 4 the lowest (i.e., a systematic failure to 
engage in loss mitigation). This rule will focus primarily on the tier 
4 performers.


Statement of Need:


This rule implements a law authorizing HUD to assess civil money 
penalties for specific types of mortgage lender violations, including 
failure to engage in loss mitigation. The law also directs HUD to 
implement regulations as it determines necessary to implement the civil 
money penalty provisions. This rule is necessary to encourage certain 
lenders that rarely engage in loss mitigation activities to do so. 
Failure to engage in loss mitigation leads to additional claims on 
FHA's insurance funds. Greater emphasis by certain lenders on loss 
mitigation will act to reduce those claims and enhance the health of 
the funds.


Summary of Legal Basis:


Section 230 of the National Housing Act (NHA), (12 U.S.C. 1715u), 
requires mortgage lenders utilizing FHA-insured financing to engage in 
loss mitigation actions upon the default of any insured mortgage. 
Section 536(b)(1)(I) of the NHA (12 U.S.C. 1735f-14(b)(1)(I)) includes 
failure to engage in loss mitigation among the activities for which HUD 
may assess civil penalties. Section 536(a) of the NHA (12 U.S.C. 1735f-
14(a)) provides that in the case of failure to engage in loss 
mitigation, the penalty may be tripled. Section 536(h) of the NHA (12 
U.S.C. 1735f-14(h)) provides that HUD shall issue regulations to 
implement these provisions as it determines is appropriate.


Alternatives:


This action is a rule of general applicability and future effect that 
does not fall into any of the rulemaking exceptions. Therefore, 
rulemaking is the only available procedure to implement these 
provisions.


Anticipated Cost and Benefits:


This rule authorizes the imposition of a penalty on those lenders that 
have poor records in the area of loss mitigation. The announcement of 
the availability of treble damages as an enforcement tool should 
encourage lenders to engage in loss mitigation activities upon default 
by mortgagors, with adherence to statutorily required loss mitigation 
activities the rule is expected to help safeguard the insurance fund in 
the form of reduced claims on the insurance fund and hence reduced 
payouts.


Risks:


This rule imposes no risks to public health, safety, or the 
environment.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           65 FR 76520                                    12/06/00
ANPRM Comment Period End                                       02/05/01
NPRM            69 FR 19906                                    04/14/04
NPRM Comment Period End                                        06/14/04
Final Action                                                   04/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Michael Reyes
Office of the Deputy Assistant Secretary for Single Family Housing
Department of Housing and Urban Development
Office of the Secretary
Phone: 405 553-7576
RIN: 2501-AC66
_______________________________________________________________________



HUD--Office of Housing (OH)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




78. HOUSING COUNSELING PROGRAM (FR-4798)
Priority:


Other Significant


Legal Authority:


12 USC 1701; 42 USC 3535(d)


CFR Citation:


24 CFR 214


Legal Deadline:


None


Abstract:


This rule would establish regulations for the Department's Housing 
Counseling program, as authorized by the Housing and Urban Development 
Act of 1968, and for which, the past several years, notices of funding 
availability are issued on an annual basis. Establishment of 
regulations would assist homeowners and tenants in improving their 
housing conditions and in meeting the responsibilities of homeownership 
and tenancy. This rule would adopt, without substantive change, the 
housing counseling program requirements with which grantees and Housing 
Counseling agencies are already familiar.


Statement of Need:


Establishment of regulations would reflect the permanency and 
importance of this program.


Summary of Legal Basis:


Section 106(a) of the Housing and Urban Development Act of 1968 defines 
housing counseling services as ``counseling and advice to tenants and 
homeowners with respect to property maintenance, financial management 
and such other matters as may be appropriate to assist them in 
improving

[[Page 72763]]

their housing conditions and in meeting the responsibilities of 
homeownership.'' Under section 106, HUD may provide counseling 
directly, or may enter into contracts with, or make grants to, and 
provide other types of assistance to eligible private or public 
organizations with special competence and knowledge in providing 
housing counseling to low- and moderate-income families for the 
purposes of providing counseling and advice to tenants and homeowners. 
Current law at 12 U.S.C. 1701x extends eligibility of housing 
counseling services for virtually all defaulting homeowners and 
tenants. In addition, section 255(d)(2)(B) of the National Housing Act, 
which authorizes mortgage insurance of home equity conversion mortgages 
(HECM) for elderly homeowners, requires that a HECM must be executed by 
a mortgagor who received ``adequate counseling by a third party (other 
than the lender).'' Certain other HUD housing programs may require 
participation in the Housing Counseling program.


Alternatives:


Under the current program, grantees and HUD-approved counseling 
agencies must refer to notices of funding availability and HUD 
handbooks for specific program procedures. The practice of consulting 
numerous sources for program information presents confusion especially 
when presented with termination of HUD-approved status and other 
related actions. Since the program has been funded annually to date, 
regulations are the appropriate vehicle to establish program 
requirements.


Anticipated Cost and Benefits:


This rule will benefit tenants, homeowners, potential homebuyers, and 
the homeless. Housing counseling assists eligible homebuyers to seek 
out and purchase homes, helps renters locate and qualify for assisted 
rental units, helps eligible homebuyers to obtain affordable housing 
and avoid foreclosures, and helps the homeless to find temporary or 
permanent shelter. The program will not add additional costs to housing 
counseling agencies or those who seek housing counseling services.


Risks:


This rule poses no risk to public health, safety, or the environment.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           01/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Loyd LaMois
Single Family Program Support Division
Department of Housing and Urban Development
Office of Housing
Phone: 202 708-0317
RIN: 2502-AH99
_______________________________________________________________________



HUD--Office of Community Planning and Development (CPD)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




79. EMPOWERMENT ZONES: RESIDENT BENEFIT AND ECONOMIC DEVELOPMENT 
STANDARDS FOR GRANTS (FR-4853)
Priority:


Other Significant


Legal Authority:


26 USC 1391; 42 USC 3535(d)


CFR Citation:


24 CFR 598


Legal Deadline:


None


Abstract:


This rule proposes to establish review standards for determining 
whether grant funds provided to Empowerment Zones will provide a 
sufficient level of benefit to residents and also be used in 
conjunction with economic development activities consistent with the 
strategic plan for each Empowerment Zone (EZ).


Statement of Need:


HUD has determined that it is appropriate to require a level of 
resident benefit from the use of funds appropriated by Congress for 
Round II EZs (HUD EZ Grant Funds). EZ residents are intended to be 
among the principal beneficiaries of the EZ program and requiring that 
HUD EZ Grant Funds provide a direct benefit to EZ residents is 
consistent with promoting such a result. In addition, HUD EZ Grant 
Funds have generally been accompanied by the explicit requirement that 
the funds be used ``in conjunction with economic development activities 
consistent with the strategic plan for each EZ.`` A number of questions 
have arisen about whether particular planned activities would fall 
within this statutory restriction. This rule proposes the standards 
that are to be used for determining whether an activity proposed for 
assistance will meet that requirement.


Summary of Legal Basis:


The strategic plan for an EZ required under 26 U.S.C. 1391 must 
address, among other issues, the extent to which poor persons and 
families will be empowered to become economically self-sufficient. The 
statutes appropriating HUD EZ Grant Funds generally require the funds 
to be used in conjunction with economic development activities.


Alternatives:


The changes made by this rule would modify regulatory requirements and, 
therefore, must also be promulgated through regulation. Nonregulatory 
alternatives (such as through HUD notice or handbook) would not be 
binding upon HUD program participants.


Anticipated Cost and Benefits:


The requirements proposed by this rule would not impact the costs of 
using HUD EZ Grant Funds, but would only provide direction for the use 
of such funds consistent with the purposes of EZ designation. The 
benefits of having this direction is that it provides more certainty 
for planning and executing activities that will promote the purposes of 
the authorizing legislation.


Risks:


This rule poses no threat to public safety, health, or the environment.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           11/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses, Governmental Jurisdictions


Government Levels Affected:


Local

[[Page 72764]]

Agency Contact:
John Haines
Empowerment Zone Division
Department of Housing and Urban Development
Office of Community Planning and Development
Phone: 202 708-6339
RIN: 2506-AC16
_______________________________________________________________________



HUD--Office of Public and Indian Housing (PIH)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




80. CAPITAL FUND PROGRAM (FR-4880)
Priority:


Other Significant


Legal Authority:


42 USC 1437g; 42 USC 1437z-7; 42 USC 3535(d)


CFR Citation:


24 CFR 905


Legal Deadline:


None


Abstract:


This rule will implement the regulatory framework for the Capital Fund 
Program for the capital and management improvement needs of public 
housing agencies that will govern the use of the assistance made 
available from the Capital Fund formula. The new rule at part 905 will 
replace and remove several other rules that currently govern a PHA's 
use of HUD assistance including part 941 (Public Housing Development) 
and part 968 (Public Housing Modernization). This rule will continue 
and expand the streamlining of procedures and requirements initiated 
under the Comprehensive Grant and Comprehensive Improvement programs 
that are included in part 968.


Statement of Need:


Assistance under the Capital Fund Program is the primary, regular 
source of funding made available by HUD to a PHA for its capital 
activities, including modernization and development of public housing. 
This rule will implement the requirements for the use of assistance 
made available under the Capital Fund program. The regulations will 
provide the appropriate notice of the legal framework for the program, 
and clear and uniform guidance for program operation.


Summary of Legal Basis:


Sections 518, 519, and 539 of the Quality Housing and Work 
Responsibility Act of 1998 (Pub.L. 105-276, approved October 21, 1998) 
(referred to as QHWRA), amending sections 9 and 5, and adding section 
35(g) of the U.S. Housing Act of 1937.


Alternatives:


The QHWRA required a formula system to be established to govern funding 
of PHAs' public housing capital needs. Guidance for administration of 
these funds necessitates a permanent legal framework rather than 
informal and sporadic HUD notices.


Anticipated Cost and Benefits:


The costs of the program as administered with one fund from which a PHA 
will fund all of its capital needs is the same as under existing 
provisions. The benefits of having one funding mechanism for all such 
needs, and the provision of additional flexibility to PHAs to manage 
their physical assets provides increased benefits to the PHAs. 
Likewise, uniform program administration of these funds will provide 
increased benefits to the PHAs.


Risks:


This rule poses no threat to public safety, health, or the environment.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           04/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
William Thorson
Director, Office of Capital Improvements
Department of Housing and Urban Development
Office of Public and Indian Housing
Phone: 202 708-1640
RIN: 2577-AC50
_______________________________________________________________________



HUD--PIH



81. OPERATING FUND ALLOCATION FORMULA (FR-4874)
Priority:


Economically Significant


Legal Authority:


42 USC 1437g; 42 USC 3535(d)


CFR Citation:


24 CFR 990


Legal Deadline:


None


Abstract:


This rule will revise the formula system for allocating funds to public 
housing agencies (PHAs) for their operation and management of public 
housing. The current formula system was developed pursuant to section 
519 of the Quality Housing and Work Responsibility Act of 1998 (title V 
of Public Law 105-276, approved October 21, 1998, 112 Stat. 2551). That 
statute amended section 9 of the United States Housing Act of 1937 to 
require development of a new formula that would change the method of 
determining the payment of operating subsidies to PHAs.


Statement of Need:


Section 519 of the Quality Housing and Work Responsibility Act requires 
HUD to develop this rule to govern funding of PHAs' operating and 
management needs.


Summary of Legal Basis:


The Consolidated Appropriations Act of 2004 requires that HUD develop 
the rule to govern funding of PHA's operating and management needs.


Alternatives:


The Consolidated Appropriations Act of 2004 requires rulemaking.


Anticipated Cost and Benefits:


The costs of the program as administered with one fund from which a 
public housing agency (PHA) will fund all of its operating and 
management needs will be the same as under existing provisions. The 
benefits of having one funding mechanism for all such needs provides 
increased benefits to the PHAs. Likewise, uniform program 
administration of these funds will provide increased benefits to the 
PHAs.


The costs of the program as administered with one fund from which a PHA 
will fund all of its operating and management needs will

[[Page 72765]]

be the same as under existing provisions. The benefits of having one 
funding mechanism for all such needs provides increased benefits to the 
PHAs. Likewise, uniform program administration of these funds will 
provide increased benefits to the PHAs.


Risks:


This rule poses no threat to public safety, health, or the environment.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           04/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Chris Kubacki
Funding and Financial Management Division
Department of Housing and Urban Development
Office of Public and Indian Housing
Phone: 202 708-4932
RIN: 2577-AC51
_______________________________________________________________________



HUD--PIH



82. NATIVE AMERICAN HOUSING ASSISTANCE AND SELF-DETERMINATION ACT 
(NAHASDA): REVISIONS TO THE INDIAN HOUSING BLOCK GRANT PROGRAM FORMULA 
(FR-4938)
Priority:


Other Significant


Legal Authority:


25 USC 4101 et seq; 42 USC 3535(d)


CFR Citation:


24 CFR 1000


Legal Deadline:


None


Abstract:


This rule would make several revisions to the Indian Housing Block 
Grant (IHBG) Program allocation formula authorized under section 302 of 
the Native American Housing Assistance and Self-Determination Act of 
1996. Through the IHBG Program, HUD provides Federal housing assistance 
for Indian tribes in a manner that recognizes the right of Indian self-
determination and tribal self-government. HUD negotiated the rule with 
active tribal participation and using the procedures of the Negotiated 
Rulemaking Act of 1990. The proposed regulatory changes reflect the 
consensus decisions reached by HUD and the tribal representatives on 
ways to improve and clarify the current regulations governing the IHBG 
Program formula.


Statement of Need:


The regulations for the IHBG program at 24 CFR 1000.306 provide that 
the IHBG allocation formula shall be reviewed within five years after 
issuance. This five-year period closed in 2003, which prompted HUD to 
establish a negotiated rulemaking committee for the purposes of 
reviewing and recommending possible changes to the allocation formula. 
The committee identified certain areas of the allocation formula that 
required clarification, were outdated, or were not operating as 
originally intended. The final rule reflects the consensus decisions 
reached by HUD and the Indian tribes on the best ways to address the 
necessary changes to the IHBG Program allocation formula.


Summary of Legal Basis:


Section 301 of NAHASDA requires that the Secretary of HUD use an 
allocation formula to make fiscal year block grants to Indian tribes 
under the IHBG program.


Alternatives:


Section 302 of NAHASDA required that the allocation formula for the 
IHBG Program be established by regulation. Accordingly, the revisions 
to the allocation formula must also be codified in HUD's regulations.


Anticipated Cost and Benefits:


The changes to the allocation formula made by the final rule will not 
impact the costs of the IHBG Program. The benefits of having the 
changes to the formula developed through negotiated rulemaking is that 
it allows Indian tribes directly affected to have a say in how the 
allocation formula will operate, and consequently to help foster 
constructive, creative and acceptable solutions to difficult problems.


Risks:


This rule poses no threat to public safety, health, or the environment.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           02/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Rodger Boyd
Deputy Assistant Secretary for Native American Programs
Department of Housing and Urban Development
Office of Public and Indian Housing
Phone: 202 401-7914
RIN: 2577-AC57
_______________________________________________________________________



HUD--PIH

                              -----------

                            FINAL RULE STAGE

                              -----------




83. PROJECT-BASED VOUCHER PROGRAM (FR-4636)
Priority:


Other Significant


Legal Authority:


42 USC 1437f(o); 42 USC 3535(d)


CFR Citation:


24 CFR 983


Legal Deadline:


None


Abstract:


The Project-Based Voucher Program replaces the Project-Based 
Certificate Program that was in existence for many years. Under the 
Project-Based Voucher Program, HUD pays rental assistance for eligible 
families to live in specific housing developments or units. A public 
housing agency (PHA) that administers a tenant-based housing choice 
voucher program may ``project-base'' up to 20 percent of voucher units 
funded by HUD. The Project-Based Program was authorized by law in 1998, 
as part of the statutory merger of the certificate and voucher tenant-
based programs. In 2000, the Congress substantially revised the 
project-based voucher law. The law made a number of changes including 
permitting a PHA to pay project-based assistance for a

[[Page 72766]]

term of up to 10 years, permitting a PHA to provide project-based 
assistance for existing housing that does not need rehabilitation, as 
well as for newly constructed or rehabilitated housing, and allowing a 
family to move from a project-based voucher unit after one year and 
transfer to the PHA's tenant-based voucher program.


Statement of Need:


This rule will implement the requirements for the new Section 8 
Project-Based Voucher program. The regulations will provide the 
appropriate notice of the legal framework for the program, and clear 
and uniform guidance for program operation for PHAs and the residents 
that the PHAs serve.


Summary of Legal Basis:


The statute is not self-implementing. Regulations are needed to present 
the legal framework for the program. The Secretary is authorized under 
the U.S. Housing Act of 1937 and the Department of Housing and Urban 
Development Act to prescribe such rules and regulations as may be 
necessary to effectively administer Department programs.


Alternatives:


This is a new program that provides assistance for housing and replaces 
a previous HUD program. Effective and fair administration of the 
program necessitates a permanent legal framework rather than informal 
and sporadic HUD notices.


Anticipated Cost and Benefits:


The new law and the regulations to be implemented by HUD provide 
additional flexibility to PHAs to manage their project-based voucher 
programs, and also provide more housing choices to the individuals and 
families served by the PHA.


Risks:


The rule poses no threat to public safety, health or the environment.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Notice          66 FR 3605                                     01/16/01
NPRM            69 FR 12950                                    03/18/04
NPRM Comment Period End                                        05/17/04
Final Action                                                   01/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Local, State


Agency Contact:
Gerald J. Benoit
Director, Housing Voucher Management and Operations
Department of Housing and Urban Development
Office of Public and Indian Housing
Phone: 202 708-0477
RIN: 2577-AC25
BILLING CODE 4210-01-S

[[Page 72767]]




DEPARTMENT OF THE INTERIOR (DOI)



Statement of Regulatory Priorities
 The Department of the Interior (DOI) is the principal Federal steward 
of our nation's public lands and resources, including many of our 
cultural treasures. We serve as trustee to Native Americans and Alaska 
natives and also are responsible for relations with the island 
territories under United States jurisdiction. We manage more than 500 
million acres of Federal lands, including 388 park units, 545 wildlife 
refuges, 24,000 miles of trails, and approximately 1.7 billion acres 
submerged in offshore waters. The Department protects natural, historic 
and cultural resources, recovers endangered species, manages water 
projects, manages forests and fights wildland fires, leases public 
lands for coal, oil and gas production to meet the Nation's energy 
needs, educates children in Indian schools and provides recreational 
opportunities for almost 300 million visitors annually in our national 
parks. To fulfill these responsibilities, the Department generates 
scientific information relating to land and resource management.
 The Department is committed to achieving its stewardship objectives in 
partnership with States, communities, landowners, and others through 
consultation, cooperation, and communication.
 We will review and update the Department's regulations and policies to 
ensure that they are effective, efficient, and promote accountability. 
Special emphasis will be given to regulations and policies that:
 Adopt performance-based approaches focusing on achieving 
            results in the most cost-effective and timely manner;
 Incorporate the best available science, and utilize peer 
            review where appropriate;
 Promote partnerships with States, other groups, and 
            individuals;
 Provide incentives for private landowners to achieve 
            conservation goals; and
 Minimize regulatory and procedural burdens, promoting 
            fairness, transparency, and accountability by agency 
            regulators while maintaining performance goals.
Major Regulatory Areas
 Among the Department's bureaus and offices, the Office of Surface 
Mining Reclamation and Enforcement (OSM) has a significant 
concentration of regulatory responsibilities. OSM, in partnership with 
the States and Indian tribes, establishes and enforces environmental 
standards for coal mining and reclamation operations. In addition, OSM 
administers the abandoned mine land reclamation program, which is 
funded by a fee assessed on each ton of coal produced. Money from these 
fees is placed in a fund that, subject to appropriation, is used to 
reclaim lands and waters impacted by historic mining activities 
conducted before the enactment of the Surface Mining Control and 
Reclamation Act of 1977. The collection of the fee for reclamation 
purposes was originally scheduled to expire in 1992 but was extended by 
the Energy Policy Act of 1992 to September 30, 2004; language in the 
Department's FY 2005 appropriation would further extend it for an as 
yet to be determined period.
 Other DOI bureaus rely on regulations to implement legislatively 
mandated programs that focus on the management of natural resources and 
public or trust lands. Some of these regulatory activities include:
 Management of migratory birds and preservation of certain 
            marine mammals and endangered species;
 Management of dedicated lands, such as national parks, 
            wildlife refuges, and American Indian trust lands;
 Management of public lands open to multiple use;
 Leasing and oversight of development of Federal energy, 
            minerals, and renewable resources;
 Management of revenues from American Indian and Federal 
            minerals;
 Fulfillment of trust and other responsibilities pertaining to 
            American Indian tribes;
 Natural resource damage assessments; and
 Management of financial and nonfinancial assistance programs.
Regulatory Policy
How DOI Regulatory Procedures Relate to the Administration's Regulatory 
Policies
Within the requirements and guidance in Executive Orders 12866, 12630, 
and 13132, DOI's regulatory programs seek to:
 Fulfill all legal requirements as specified by statutes or 
            court orders;
 Perform essential functions that cannot be handled by non-
            Federal entities;
 Minimize regulatory costs to society while maximizing societal 
            benefits; and
 Operate programs openly, efficiently, and in cooperation with 
            Federal and non-Federal entities.
 DOI bureaus have taken the initiative in working with other Federal 
agencies, non-Federal government agencies, and public entities to make 
our regulations easier to comply with and understand. Regulatory 
improvement is a continuing process that requires the participation of 
all affected parties. We strive to include all affected entities in the 
decisionmaking process and to issue rules efficiently. To better manage 
and review the regulatory process, we have revised our internal 
rulemaking and information quality guidance. Our regulatory process 
ensures that bureaus share ideas on how to reduce regulatory burdens 
while meeting the requirements of the laws they enforce and improving 
their stewardship of the environment and resources under their purview. 
Results have included:
 Increased bureau awareness of and responsiveness to the needs 
            of small businesses and better compliance with the Small 
            Business Regulatory Enforcement Fairness Act (SBREFA);
 A Departmentwide effort to evaluate the economic effects of 
            planned rules and regulations;
 Issuance of guidance in the Departmental Manual to ensure the 
            use of plain language;
 Issuance of new guidance in the Departmental Manual to ensure 
            that Departmental National Environmental Policy Act reforms 
            that streamline decisionmaking and enhance citizen 
            participation are institutionalized; and
 In the Natural Resources Damage Assessment Program, de-
            emphasizing actions stemming from litigation while 
            increasing outreach to involved parties and stressing 
            cooperation and restoration of affected sites.
 A Departmentwide effort to streamline decisionmaking 
            pertaining to fuels reduction projects under the Healthy 
            Forests Initiative; and
 Joint counterpart pesticide regulations for EPA/FWS endangered 
            species consultations that will allow the agencies to work 
            together to complete the consultations (25,000 backlog) in

[[Page 72768]]

            as timely a manner as possible and as efficiently as 
            possible.
Implementing the President's National Energy Policy
 The President's National Energy Policy promotes ``dependable, 
affordable, and environmentally sound production and distribution of 
energy for the future.'' The Department of the Interior plays a vital 
role in implementing the President's energy policy goals. The lands and 
facilities managed by the Department account for nearly 30 percent of 
all the energy produced in the United States.
 The Department is taking over 100 actions to implement the President's 
energy policy, including several regulatory actions. The Department has 
diligently completed regulatory tasks assigned to it by the NEP, 
including the Bureau of Land Management's rule that provides a 
comprehensive set of regulations for managing oil and gas leases in the 
National Petroleum Reserve B Alaska, and the Minerals Management 
Service's rule that provides an incentive for development of deep gas 
resources offshore in order to encourage drilling of these high-risk 
wells and help tap into an important new source of natural gas supply. 
The Office of Surface Mining is developing regulations that will create 
a stable regulatory environment in order to encourage the development 
of better mining and reclamation practices that will reduce 
environmental damages associated with coal operations, while 
maintaining coal production. OSM anticipates that Congress will 
reauthorize the Abandoned Mine Land Fee. However, OSM is making 
contingency rulemaking plans should Congress decide otherwise. These 
and other regulatory actions within the Department are designed to 
streamline permitting processes and encourage environmentally sound 
energy production.
Encouraging Responsible Management of the Nation's Resources
 The Department's mission includes protecting and providing access to 
our Nation's natural and cultural heritage and honoring our trust 
responsibilities to tribes. We are committed to this mission and to 
applying laws and regulations fairly and effectively. The Department's 
priorities include protecting public health and safety, restoring and 
maintaining public lands, ameliorating land and resource-management 
problems on public lands, and ensuring accountability and compliance 
with Federal laws and regulations.
 Consistent with the President's Executive Order on Cooperative 
Conservation, the Department is continuing to work together with State 
and local governments, landowners, conservation groups, and the 
business community to conserve species and habitat. Building on 
successful approaches such as habitat conservation plans, safe harbor 
agreements, and candidate conservation agreements, the Department is 
reviewing its policies and regulations to identify opportunities to 
streamline the regulatory process where possible, consistent with 
protection of wildlife, and to enhance incentive-based programs to 
encourage landowners and others to implement voluntary conservation 
measures. For example, the Fish and Wildlife Service has issued 
guidance to promote the establishment of conservation banks as a tool 
to offset adverse impacts to species listed under the Endangered 
Species Act and restore habitat.
 The Department is improving incentives through administrative 
flexibility under the Endangered Species Act. Released for public 
comment in September 2003 are proposed rule changes intended to provide 
greater clarity of what is allowable under incidental take permits and 
provide greater private landowner protections under safe harbor 
agreements. The first improvements of procedures relate to enhancement 
of survival permits (actions intended to improve survival or habitat of 
a species) and will refine and clarify the application requirements. 
The second, which relates to the issuing of safe harbor permits, will 
make the process easier to understand and will provide participating 
landowners greater certainty. Comments have been received and are being 
reviewed. Final rules on both will follow sometime before the end of 
the year.
The Department is also developing a uniform code of scientific conduct 
and policy on research. The Code describes ethical conduct for all 
Department employees who are engaged in conducting scientific 
activities on behalf of the Department. The primary reason for 
developing the Code is to implement a Federal policy on research 
misconduct as required by the Office of Management and Budget. The 
policy applies to all Federal agencies and federally funded research, 
whether conducted in-house or by partners at universities or in non-
governmental organizations. This policy meets the expectations of the 
Secretary regarding the conduct of scientific activities with honesty, 
integrity, and accuracy; to make decisions based on the best science 
available; and is consistent with professional codes of conduct of 
other organizations.
 In 2002, Secretaries Norton and Veneman signed an historic agreement 
with 17 western governors, county commissioners and other affected 
parties on a plan to make communities safer from wildfires through 
coordinating Federal, State and local action. Under the 10-year 
Comprehensive Strategy Implementation Plan, Federal wildfire agencies, 
affected States, counties, and local governments agreed to the same 
goals, implementation outcomes, performance measures and tasks that 
need to be accomplished by specific deadlines. The plan covers all 
phases of the fire program, including fire preparedness, suppression 
and prevention, hazardous fuels management, restoration of burned 
areas, community assistance and monitoring of progress.
 In 2002, the President announced the Healthy Forests Initiative, in 
which he directed Federal agencies to develop administrative and 
legislative tools to restore forests and woodlands to more healthy, 
natural conditions and to assist in executing core components of the 
National Fire Plan. The Healthy Forests Initiative is providing public 
land managers the tools to undertake commonsense management of our 
forests and woodlands. The initiative focuses on reducing the risk of 
catastrophic fire by thinning dense undergrowth and brush in priority 
locations that are collaboratively selected by Federal, State, tribal, 
and local officials and communities. In 2005, the Department will 
continue to implement the administrative and legislative ``tools'' 
provided for under the Healthy Forests Initiative and the Healthy 
Forests Restoration Act.
The National Park Service has completed an Environmental Assessment to 
provide for Temporary Winter Use Plan that provides for continued 
snowmobile and snowcoach use in Yellowstone and Grand Teton National 
Parks and John D. Rockefeller, Jr. Memorial Parkway for up to the next 
three winter seasons. This EA will allow the NPS to engage in longer-
term studies and to monitor the impacts of new technology snowmobiles 
in the parks, as well as the effects of road grooming in the winter on 
bison migration in Yellowstone. The EA will continue to require the use 
of cleaner, quieter

[[Page 72769]]

snowmobiles and set caps on the numbers of machines allowed in the 
parks each day. The parks are working to provide a more stable winter 
use plan to help gateway communities develop a winter economic plan. 
The interim plan and longer-term studies are both intended to satisfy 
the problems raised by the Federal District Courts in Wyoming and the 
District of Columbia, respectively, that have vacated the plans 
previously completed by the NPS in 2001 and 2003.
The Bureau of Land Management is working on a grazing administration 
rule that would ensure grazing decision rules conform with the 
Administrative Procedure Act, compliance with recent court decisions 
regarding conservation use permits, require BLM to consider social and 
economic factors when considering changes to grazing use, and offer 
other improvements to grazing activities on public lands.
On September 20, 2004, the U.S. Oceans Commission issued its report, 
which included over 200 recommendations. The Interior Department will 
play an active role in developing the Administration's initial response 
(the President has 90 days to respond), given the significant ocean and 
coastal related activities of many of Interior's agencies. In 2005, it 
is expected that significant time will be devoted to policy, 
regulatory, and legislative activities likely to occur as a result of 
the issuance of the report.
Minimizing Regulatory Burdens
We are using the regulatory process to ease the burdens on various 
entities throughout the country while improving results. For instance, 
the Endangered Species Act (ESA) allows for the delisting of threatened 
and endangered species if they no longer need the protection of the 
ESA. We have identified approximately 40 species for which delisting or 
downlisting (reclassification from endangered to threatened) may be 
appropriate. The eastern gray wolf has been delisted and an ESA section 
10(j) rule for S tates with approved management plans will be ready in 
December.
 The Federal Power Act authorizes the Department to include in 
hydropower licenses issued by the Federal Energy Regulatory Commission 
conditions and prescriptions necessary to protect Federal and tribal 
lands and resources and to provide fishways when navigable waterways or 
Federal reservations are used for hydropower generation. Over the past 
year, the Department has worked extensively with the Federal Energy 
Regulatory Commission (FERC), along with the Departments of Commerce 
and Agriculture, to establish a new integrated licensing process that 
will reduce both the time and cost of obtaining a FERC hydropower 
license. In July 2003 FERC issued its new rules. On September 9, DOI 
published a proposed rule on FERC licensing. The public review process 
will enable the public and the license applicant to comment on the 
Department's preliminary conditions and prescriptions, and to provide 
information to assist the Department in its formulation of modified 
conditions and prescriptions. The information obtained through this 
process will help the Department in refining and developing its 
conditions and prescriptions, which an applicant may appeal using the 
proposed appeals process to obtain an expeditious policy level review. 
These proposed processes are designed to coincide with and complement 
the Commission's overall licensing process.
Encouraging Public Participation and Involvement in the Regulatory 
Process
 The Department is encouraging increased public participation in the 
regulatory process to improve results by ensuring that regulatory 
policies take into account the knowledge and ideas of our customers, 
regulated community, and other interested participants. The Department 
is reaching out to communities to seek public input on a variety of 
regulatory issues. For example, every year FWS establishes migratory 
bird hunting seasons in partnership with ``flyway councils,'' which are 
made up of State fish and wildlife agencies. As the process evolves 
each year, FWS holds a series of public meetings to give other 
interested parties, including hunters and other groups, opportunities 
to participate in establishing the upcoming season's regulations.
 Similarly, the Bureau of Land Management (BLM) uses Resource Advisory 
Councils (RACs) made up of affected parties to help prepare land 
management plans and regulations that it issues under the Rangeland 
Reform Act.
 In addition, the Department has recently completed a review of its 
NEPA compliance program and proposed new procedures aimed at improving 
public participation and reducing excess paperwork and redundancy of 
effort in the field. This has led to concrete reform measures. On March 
8, 2004, the Department published its final revised procedures in the 
Federal Register. The reforms cover a number of areas. They include: 
Consensus-based management, public participation, community-based 
training, use of integrated analysis, adaptive management, and tiered 
and transferred analysis. Each of these concepts is aimed at ensuring 
the field staff have the tools to tailor their approach to the NEPA 
process to local needs and interests. Along with the departmental 
manual changes, policy guidance was distributed to bureaus earlier this 
year on how to implement the major reforms.
 We encourage public consultation during the regulatory process. For 
example:
 OSM is continuing its outreach to interested groups to improve 
            the substance and quality of rules and, to the greatest 
            extent possible, achieve consensus on regulatory issues;
 The Bureau of Indian Affairs has finalized its roads program 
            rule that was developed using the negotiated rulemaking 
            process, which has resulted in a rule that better serves 
            the diverse needs of the Native American community, 
            reflecting the importance of the roads program to the 
            individual tribes and the varying needs of the tribal 
            governments;
 The Golden Gate National Recreation Area, a unit of the 
            National Park System, has engaged in negotiated rulemaking 
            to resolve an issue regarding walking dogs off-leash in the 
            park. Existing NPS regulations require all dogs to be on a 
            leash while in Golden Gate NRA, and the park has asked 
            interested parties on both sides of the issue to come to 
            the table to help draft a proposed rule. The effort has 
            identified over 20 area organizations that will likely 
            participate in the negotiated rulemaking process.
Regulatory Actions Related to the Events of September 11, 2001
 The Bureau of Reclamation is responsible for protecting 348 reservoirs 
and more than 500 Federal dams, 58 hydroelectric plants, and over 8 
million acres of Federal property. Public Law 107-69 granted 
Reclamation law enforcement authority for its lands. Reclamation 
finalized an interim rule published in April 2002 for one year that 
implements this authority. It has since been extended through 2005.
Rules of Particular Interest to Small Businesses
 The National Park Service snowmobiling rule for Yellowstone and Grand 
Teton National Parks and the

[[Page 72770]]

John D. Rockefeller Memorial Parkway is of great interest to small 
businesses in the area of the parks, in particular those who rent 
snowmobiles. An initial Regulatory Flexibility Analysis points toward 
economic benefits to businesses in gateway communities, with some costs 
incurred by non-snowmobile users of the parks.
 The Fish and Wildlife Service is making critical habitat designations 
more site-specific and is using the ESA section 4(b) exclusion process 
to reduce regulatory costs on small businesses.
The Future of DOI
 Interior has developed a new Departmentwide strategic plan in response 
to Congressional, OMB and other appraisals indicating that Interior's 
ten separate strategic planning documents are too long and lack the 
appropriate agency-level focus. The process of developing the new 
strategic plan provides the Secretary with an opportunity to:
 Incorporate key Administration and Secretarial priorities into 
            Interior's goals and performance measures;
 Consult with key interested constituents on the future 
            direction of the Department; and
 Make Interior programs more ``results-oriented'' and 
            accountable to citizens.
 Interior also is using the single Strategic Plan as the basis for 
preparing a single Departmentwide Annual Performance Plan beginning 
with the plan for FY 2004. The Interior bureaus will continue to 
prepare internal plans to support their budget initiatives and to meet 
management excellence and accountability needs. However, we plan to 
submit only Departmentwide strategic and annual plans to the Congress.
Bureaus and Offices Within DOI
The following brief descriptions summarize the regulatory functions of 
DOI's major regulatory bureaus and offices.
Bureau of Indian Affairs
The Bureau of Indian Affairs (BIA) is responsible for managing trust 
responsibilities to the Indian tribes and encouraging tribal 
governments to assume responsibility for BIA programs.
The Bureau's rulemaking and policy development processes are designed 
to foster public and tribal awareness of the standards and procedures 
that directly affect them. The processes also encourage the public and 
the tribes to participate in developing these standards and procedures. 
The goals of BIA regulatory policies are to: (a)?Ensure consistent 
policies within BIA that result in uniform interactions with the tribal 
governments, (b) facilitate tribal involvement in managing, planning, 
and evaluating BIA programs and services, and (c) ensure continued 
protection of tribal treaties and statutory rights.
 Under the No Child Left Behind Act of 2001, the Secretary of the 
Interior established a negotiated rulemaking committee to develop 
proposed rules to implement several sections of the Act relating to the 
Bureau of Indian Affairs-funded school system. The committee is 
comprised only of representatives of tribes and tribally operated 
schools and the Federal Government. The tribal representative 
membership reflects the proportionate share of students from tribes 
served by the Bureau-funded school system. This committee has 
negotiated rules to implement portions of the No Child Left Behind Act 
affecting the definition of ``Adequate Yearly Progress,'' attendance 
boundaries for Bureau-funded schools, funding for Bureau-funded 
schools, rights of students in the Bureau-funded school system, and 
grants under the Tribally Controlled Schools Act. The proposed rule was 
published in the Federal Register on February 25, 2004. The Bureau and 
the negotiated rulemaking committee have reviewed the comments on the 
proposed rule and their recommendations are being incorporated into the 
final rule that is now under preparation.
Bureau of Land Management
The BLM manages about 262 million acres of land surface and about 700 
million acres of Federal mineral estate. These lands consist of 
extensive grasslands, forests, mountains, arctic tundra, and deserts. 
Resources on the lands include energy and minerals, timber, forage, 
wild horse and burro populations, habitat for fish and wildlife 
species, wilderness areas and archaeological and cultural sites. The 
BLM manages these lands and resources for multiple purposes and the 
sustained yield of renewable resources. Primary statutes under which 
the Agency must operate include: the Federal Land Management and Policy 
Act of 1976; the General Mining Act of 1872; the Mineral Leasing Act of 
1920, as amended; the Recreation and Public Purposes Act; the Taylor 
Grazing Act; the Wilderness Act; and the Wild Free-Roaming Horses and 
Burros Act.
The Regulatory Program mirrors statutory responsibilities and Agency 
objectives including the following:
 Providing for a wide variety of public uses while maintaining 
            the long-term health and diversity of the land while 
            preserving significant natural, cultural, and historic 
            resource values;
 Understanding the arid, semi-arid, arctic, and other 
            ecosystems we manage and our commitment to using the best 
            scientific and technical information to make resource 
            management decisions;
 Understanding the needs of the public that use the BLM-managed 
            lands and providing them with quality service;
 Committing to recover a fair return for using publicly owned 
            resources and avoiding the creation of long-term 
            liabilities for American taxpayers; and
 Resolving problems and implementing decisions in cooperation 
            with other agencies, States, tribal governments, and the 
            public.
The Regulatory Program contains its own objectives. These include 
preparing regulations that:
 Are the product of communication, coordination, and 
            consultation with all affected members of the public;
 Are easy for the public to understand, especially those who 
            would be most affected by them; and
 Are subject to periodic review to determine whether the rules 
            are outdated, whether they require updating to reflect 
            statutory and policy changes and whether they are achieving 
            desired results.
The BLM's regulatory priorities include:
 Completing oil and gas leasing and operations regulations to 
            make the program more efficiently serve the regulated 
            public;
 Completing updating and consolidating the regulations on 
            locating, filing, and maintaining mining claims and mill 
            and tunnel sites, to remove unnecessary and outdated 
            provisions, reorder the regulations more logically, and 
            make them easier to read and understand; and
 Revising the regulations on administrative rights-of-way on 
            the public lands to increase cost recovery to levels that 
            properly compensate BLM for our administrative and 
            monitoring costs, and to raise the cap on strict liability 
            for right-of-way

[[Page 72771]]

            holders to a reasonable level for costs associated with 
            environmental cleanup.
 Most of BLM's regulations affect small business because many business 
entities that operate on public lands meet the definition of a small 
business established by the Small Business Administration (SBA). BLM's 
regulations do not specifically target small businesses. BLM strives to 
ensure that our regulations do not unduly burden entities whether or 
not they are considered small businesses.
 BLM's mining and grazing projects likely generate the greatest concern 
to small businesses because most livestock operators and mining 
companies are also considered small businesses, as classified by SBA.
 The final grazing rule that BLM intends to publish before the end of 
the calendar year will amend grazing regulations that BLM promulgated 
on February 22, 1995 (59 FR 29206). The final rule will not 
substantively change the existing rules. When published, the rule will 
rely on the regulatory flexibility analysis prepared by BLM for the 
1995 final rule. At that time, we determined that the 1995 rule should 
not have a significant impact on a substantial number of small 
entities.
 The proposed minerals cost recovery rule will increase many fees and 
impose several new fees to cover BLM's costs of processing certain 
documents related to its mineral programs. The proposed rule will 
affect a large number of small entities since nearly all of them will 
face fee increases for activities on public lands. However, we have 
concluded that the effects will not be significant. The BLM completed a 
threshold analysis, which is available for public review at 
www.blm.gov/nhp/news/regulatory/index.htm.
Minerals Management Service
The Minerals Management Service (MMS) has two major responsibilities. 
The first is timely and accurate collection, distribution, accounting 
for, and auditing of revenues owed by holders of Federal onshore, 
offshore, and Indian mineral leases in a manner that meets or exceeds 
Federal financial integrity requirements and recipient expectations. 
The second is management of the resources of the Outer Continental 
Shelf in a manner that provides for safety, protection of the 
environment, and conservation of natural resources. These 
responsibilities are carried out under the provisions of the Federal 
Oil and Gas Royalty Management Act, the Minerals Leasing Act, the Outer 
Continental Shelf Lands Act, the Indian Mineral Leasing Act, and other 
related statutes.
For the Minerals Revenue Management program (MRM), we issued a final 
Federal Oil Valuation Rule (1010-AD04), published in the Federal 
Register on May 5, 2004, at 69 FR 24959, with an effective date of 
August 1, 2004), which amends current regulations at 30 CFR part 206. 
These amendments primarily affect which published market prices are 
most appropriate to value crude oil not sold at arm's-length and what 
transportation deductions should be allowed. MRM issued another final 
rule (1010-AC30, published in the Federal Register on September 13, 
2004, at 69 FR 55076, with an effective date of September 13, 2004), 
which implements certain provisions in the Federal Oil and Gas Royalty 
Simplification and Fairness Act of 1996. These regulations explain how 
lessees and their designees can obtain accounting and auditing relief 
for production from Federal oil and gas leases and units and 
communitization agreements that qualify as marginal properties.
We also plan to continue our review of existing regulations and to 
issue rules to refine the Minerals Revenue Management (MRM) regulations 
in chapter II of 30 CFR.? MRM is in the process of issuing regulations 
to: (1) revise its oil valuation regulations for Indian leases; (2) 
revise gas valuation regulations for Federal leases; and (3) codify 
provisions in the Federal Oil and Gas Royalty Simplification and 
Fairness Act of 1996.
Office of Surface Mining Reclamation and Enforcement
The Office of Surface Mining Reclamation and Enforcement ( OSM) was 
created by the Surface Mining Control and Reclamation Act of 1977 
(SMCRA) to ``strike a balance between protection of the environment and 
agricultural productivity and the Nation's need for coal as an 
essential source of energy.''
The principal regulatory provisions contained in title V of SMCRA set 
minimum requirements for obtaining a permit for surface coal mining 
operations, set standards for those operations, require land 
reclamation once mining ends, and require rules and enforcement 
procedures to ensure that the standards are met. Under SMCRA, OSM is 
the primary enforcer of SMCRA's provisions until the States achieve 
``primacy;'' that is, until they demonstrate that their regulatory 
programs meet all the specifications in SMCRA and have regulations 
consistent with those issued by OSM.
When a primacy State takes over the permitting, inspection, and 
enforcement activities of the Federal Government, OSM then changes its 
role from regulating mining activities directly to overseeing and 
evaluating State programs. Today, 24 of the 26 key coal-producing 
States have primacy. In return for assuming primacy, States are 
entitled to regulatory grants and to grants for reclaiming abandoned 
mine lands. In addition, under cooperative agreements, some primacy 
States have agreed to regulate mining on Federal lands within their 
borders. Thus, OSM regulates mining directly only in nonprimacy States, 
on Federal lands in States where no cooperative agreements are in 
effect, and on Indian lands.
SMCRA charges OSM with the responsibility of publishing rules as 
necessary to carry out the purposes of the Act. The fundamental 
mechanism for ensuring that the purposes of SMCRA are achieved is the 
basic policy and guidance established through OSM's permanent 
regulatory program and related rulemakings. This regulatory framework 
is developed, reviewed, and applied according to policy directives and 
legal requirements.
Litigation by the coal industry and environmental groups is responsible 
for some of the rules now being considered by OSM. Others are the 
result of efforts by OSM to address areas of concern that have arisen 
during the course of implementing OSM's regulatory program, and two are 
the result of legislation.
OSM has sought to develop an economical, safe, and environmentally 
sound program for the surface mining of coal by providing a stable, 
consistent regulatory, results-focused framework. At the same time, 
however, OSM has recognized the need (a) to respond to local 
conditions, (b) to provide flexibility to react to technological 
change, (c) to be sensitive to geographic diversity, and (d) to 
eliminate burdensome recordkeeping and reporting requirements that over 
time have proved unnecessary to ensure an effective regulatory program.
Major regulatory objectives regarding the mining of surface coal 
include:
 Regulatory certainty so that coal companies know what is 
            expected of them and citizens know what is intended and how 
            they can participate;

[[Page 72772]]

 Ensuring an affordable, reliable energy supply while 
            protecting the environment.
 Continuing consultation, cooperation, and communication with 
            interest groups during the rulemaking process in order to 
            increase the quality of the rulemaking, and, to the 
            greatest extent possible, reflect consensus on regulatory 
            issues.
U.S. Fish and Wildlife Service
The mission of the U.S. Fish and Wildlife Service is working with 
others to conserve, protect, and enhance fish, wildlife, and plants and 
their habitats for the continuing benefit of the American people. Four 
principal mission goals include:
 The sustainability of fish and wildlife populations. 
            FWS conserves, protects, restores, and enhances fish, 
            wildlife, and plant populations entrusted to its care. They 
            carry out this mission goal through migratory bird 
            conservation at home and abroad; native fisheries 
            restoration; recovery and protection of threatened and 
            endangered species; prevention and control of invasive 
            species; and work with our international partners.
 Habitat conservation through a network of lands and 
            waters. Cooperating with others, FWS strives to conserve an 
            ecologically diverse network of lands and waters of various 
            ownership that provide habitat for fish, wildlife, and 
            plant resources. This mission goal emphasizes two kinds of 
            strategic actions: (1) The development of formal agreements 
            and plans with partners who provide habitat for multiple 
            species, and (2) the actual conservation work necessary to 
            protect, restore, and enhance those habitats vital to fish 
            and wildlife populations. The FWS's habitat conservation 
            strategy focuses on the interaction and balance of people, 
            lands and waters, and fish and wildlife through an 
            ecosystem approach.
 Public use and enjoyment. FWS provides opportunities 
            to the public to enjoy, understand, and participate in the 
            use and conservation of fish and wildlife resources. The 
            Service directs activities on national wildlife refuges and 
            national fish hatcheries that increase opportunities for 
            public involvement with fish and wildlife resources. Such 
            opportunities include hunting, fishing, wildlife 
            observation and photography, and environmental education 
            and interpretation, as well as hands-on experiences through 
            volunteer conservation activities on Service lands.
 Partnerships in natural resources. FWS supports and 
            strengthens partnerships with tribal, State, and local 
            governments and others in their efforts to conserve and 
            enjoy fish, wildlife, and plants and habitats, consistent 
            with the President's Executive Order on Cooperative 
            Conservation. FWS administers Federal grants to States and 
            territories for restoration of fish and wildlife resources 
            and has a continuing commitment to work with tribal 
            governments. FWS also promotes partnerships with other 
            Federal agencies where common goals can be developed.
 The Service carries out these mission goals through several types of 
regulations. While carrying out its responsibility to protect the 
natural resources entrusted to our care, FWS works continually with 
foreign and State governments, affected industries and individuals, and 
other interested parties to minimize any burdens associated with its 
activities. In carrying out its assistance programs, the Service 
administers regulations to help interested parties obtain Federal 
assistance and then comply with applicable laws and Federal 
requirements.
 Some Service regulations permit activities otherwise prohibited by 
law. These regulations allow possession, sale or trade, scientific 
research, and educational activities involving fish and wildlife and 
their parts or products. In general, these regulations supplement State 
regulations and cover activities that involve interstate or foreign 
commerce.
 FWS enforces regulations that govern public access, use, and 
recreation on more than 545 national wildlife refuges and in national 
fish hatcheries. The Service authorizes only uses that are compatible 
with the purpose for which each area was established, are consistent 
with State and local laws where practical, and afford the public 
appropriate economic and recreational opportunity.
FWS administers regulations to manage migratory bird resources. 
Annually, the Service issues a regulation on migratory bird hunting 
seasons and bag limits that is developed in partnership with the 
States, tribal governments, and the Canadian Wildlife Service. These 
regulations are necessary to permit migratory bird hunting that would 
otherwise be prohibited by various international treaties.
 Finally, FWS implements regulations under the Endangered Species Act 
(ESA) to fulfill its statutory obligation to identify and conserve 
species faced with extinction and to conserve certain mammals under the 
Marine Mammal Protection Act. The ESA dictates that the basis for 
determining endangered and threatened species must be limited to 
biological considerations. Regulations enhance the conservation of ESA-
listed species and help other Federal agencies comply with the ESA. 
Under section 7 of the ESA, all Federal agencies must consult with the 
Service on actions that may jeopardize the continued existence of 
endangered or threatened species or result in the destruction or 
adverse modification of their critical habitats.
 In designating critical habitat for listed species, the Service 
considers biological information and economic and other impacts of the 
designation. Areas may be excluded if the benefits of exclusion 
outweigh the benefits of inclusion, provided that such exclusion will 
not result in the extinction of the species. The Department is 
reviewing guidance for designation of critical habitat. The guidance 
will provide policy direction and a process for developing critical 
habitat designations
 Section 4(f)(1) of the ESA directs the Secretary of the Interior to 
develop and implement plans (known as recovery plans) for the 
conservation and survival of endangered and threatened species. The 
Service has been coordinating with the National Marine Fisheries 
Service to revise the joint Recovery Planning Guidance for the recovery 
of endangered and threatened species under the ESA. The purpose of the 
proposed guidance is to achieve greater consistency in the 
implementation of the ESA while working with our partners. In addition, 
section 6 of the ESA pertains to cooperation with the States in the 
conservation of endangered and threatened species. The Department will 
also issue guidance to facilitate better coordination with the States 
and provide more opportunities for the States' direct involvement in 
managing endangered and threatened species.
National Park Service
The National Park Service is dedicated to conserving the natural and 
cultural resources and values of the National Park System for the 
enjoyment, education, and inspiration of this and future generations. 
The Service also manages a great variety of national and international 
programs designed to help

[[Page 72773]]

extend the benefits of natural and cultural resource conservation and 
outdoor recreation throughout this country and the world.
 There are 388 units in the National Park System, including national 
parks and monuments; scenic parkways, preserves, trails, riverways, 
seashores, lakeshores, and recreation areas; and historic sites 
associated with important movements, events, and personalities of the 
American past. The NPS develops and implements park management plans, 
and staffs the areas under its administration. It relates the natural 
values and historical significance of these areas to the public through 
talks, tours, films, exhibits, and other interpretive media. It 
operates campgrounds and other visitor facilities and provides, usually 
through concessions, lodging, food, and transportation services in many 
areas.
 The NPS also administers the following programs: the State portion of 
the Land and Water Conservation Fund; Federal Lands to Parks; 
Nationwide outdoor recreation coordination and information, and State 
Comprehensive Outdoor Recreation Planning; Rivers, Trails and 
Conservation Assistance; National Trails System; Hydropower Recreation 
Assistance; National Register of Historic Places; National Historic 
Landmarks; National Natural Landmarks; American Battlefield Protection; 
National Maritime Heritage Grants; Native American Graves Protection 
and Repatriation; Tribal Heritage Preservation Grants; Technical 
Preservation Services; Historic American Buildings Survey; Historic 
American Engineering Record; Historic American Landscapes Survey; and 
Interagency Archeological Services.
The NPS's regulatory activities focus on management of the National 
Park System and management of the programs assigned to it by Congress 
(and listed in the previous paragraph). Park-related regulations are 
designed to protect park resources while encouraging appropriate uses 
of the parks, consistent with each park's mission. Those regulations 
help ensure safe and sustainable public use, access, and recreation in 
the parks. Program-related regulations establish the procedures and 
standards by which the NPS will implement its legislated program 
responsibilities regarding, for example, the National Register Program 
and the Native American Graves Protection and Repatriation Act. The NPS 
regulatory program develops and reviews regulations for consistency 
with statutory law, current Administration priorities, and Servicewide 
policies.
Bureau of Reclamation
The Bureau of Reclamation's mission is to manage, develop, and protect 
water and related resources in an environmentally and economically 
sound manner in the interest of the American public. To accomplish this 
mission, Reclamation applies management, engineering, and scientific 
skills that result in effective and environmentally sensitive 
solutions.
Reclamation projects provide for some or all of the following 
concurrent purposes: Irrigation water service, municipal and industrial 
water supply, hydroelectric power generation, water quality 
improvement, groundwater management, fish and wildlife enhancement, 
outdoor recreation, flood control, navigation, river regulation and 
control, system optimization, and related uses. Reclamation has 
increased security at its facilities and is implementing its law 
enforcement authorization received in November 2001.
Reclamation's regulatory program is designed to ensure that its mission 
is carried out expeditiously, efficiently, and with an emphasis on 
cooperative problemsolving.
Office of the Secretary, Natural Resource Damage Assessment and 
Restoration Program
The regulatory functions of the Natural Resource Damage Assessment and 
Restoration Program (Restoration Program) stem from requirements under 
section 301(c) of the Comprehensive Environmental Response, 
Compensation, and Liability Act of 1980, as amended (CERCLA). Section 
301(c) requires the development of natural resource damage assessment 
rules and the biennial review and revisions, as appropriate, of these 
rules. Rules have been promulgated for the optional use of natural 
resource trustees to assess compensation for damages to natural 
resources caused by hazardous substances. The Restoration Program is 
overseeing the study and possible promulgation of additional rules 
pursuant to section 301(c)(2) and the review and possible revision of 
the existing rule in compliance with section 301(c)(3).
_______________________________________________________________________



DOI--Minerals Management Service (MMS)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




84. VALUATION OF OIL FROM INDIAN LEASES
Priority:


Other Significant


Legal Authority:


25 USC 2101 et seq; 25 USC 396 et seq; 25 USC 396a et seq; 30 USC 1701 
et seq


CFR Citation:


30 CFR 206


Legal Deadline:


None


Abstract:


This rule would modify the regulations that establish royalty value for 
oil produced from Indian leases and create a new form for collecting 
value and differential data. These changes would decrease reliance on 
oil posted prices and make Indian oil royalty valuation more consistent 
with the terms of Indian leases.


Statement of Need:


Current oil valuation regulations rely on posted prices and prices 
under arm's-length sales to value oil that is not sold at arm's-length. 
Over time, posted prices have become increasingly suspect as a fair 
measure of market value. This rulemaking would modify valuation 
regulations to place substantial reliance on the higher of crude oil 
spot prices, major portion prices, or gross proceeds, and eliminate any 
direct reliance on posted prices. This rulemaking would also add more 
certainty to valuation of oil produced from Indian leases.


Summary of Legal Basis:


The primary legal basis for this rulemaking is the Federal Oil and Gas 
Royalty Management Act of 1982, as amended, which defines the Secretary 
of the Interior's (1) authority to implement and maintain a royalty 
management system for oil and gas leases on Indian lands, and (2) trust 
responsibility to administer Indian oil and gas resources.


Alternatives:


We considered a range of valuation alternatives such as making minor 
adjustments to the current gross

[[Page 72774]]

proceeds valuation method, using futures prices, using index-based 
prices with fixed adjustments for production from specific geographic 
zones, relying on some type of field pricing other than posted prices, 
and taking oil in-kind. We chose the higher of the average of the high 
daily applicable spot prices for the month, major portion prices in the 
field or area, or gross proceeds received by the lessee or its 
affiliate. We chose spot prices as one of the three value measures 
because: (1) they represent actual trading activity in the market; (2) 
they mirror New York Mercantile Exchange futures prices; and (3) they 
permit use of an index price for the market center nearest the lease 
for oil most similar in quality to that of the lease production.


Anticipated Cost and Benefits:


We estimate compliance with this rulemaking would cost the oil industry 
approximately $5.4 million the first year and $4.9 million each year 
thereafter. These estimates include the up-front computer programming 
and other administrative costs associated with processing the new form. 
The monetary benefits of this rulemaking are an estimated $4.7 million 
increase in annual royalties collected on oil produced from Indian 
leases. Additional benefits include simplification and increased 
certainty of oil pricing, reduced audit efforts, and reduced valuation 
determinations and associated litigation.


Risks:


The risk of not modifying current oil valuation regulations is that 
Indian recipients may not receive royalties based on the highest price 
paid or offered for the major portion of oil produced--a common 
requirement in most Indian leases. These modifications ensure that the 
Department fulfills its trust responsibilities for administering Indian 
oil and gas leases under governing mineral leasing laws, treaties, and 
lease terms.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           60 FR 65610                                    12/20/95
NPRM            63 FR 7089                                     02/12/98
NPRM Comment Period Extended                                   04/09/98
NPRM Comment Period End                                        05/13/98
Comment Period E65 FR 1043603/20/2000                          02/28/00
Supplemental NPRM                                              12/00/04
Supplemental NPRM Comment Period End                           02/00/05
Final Action                                                   04/00/05
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


Tribal


Agency Contact:
Sharron Gebhardt
Regulatory Specialist
Department of the Interior
Minerals Management Service
MS 302B2
P.O. Box 25165
Denver, CO 80225-3211
Phone: 303 231-3211
Fax: 303 231-3385
Email: [email protected]
Related RIN: Previously reported as 1010-AC24
RIN: 1010-AD00
_______________________________________________________________________



DOI--Bureau of Land Management (BLM)

                              -----------

                            FINAL RULE STAGE

                              -----------




85. GRAZING ADMINISTRATION--EXCLUSIVE OF ALASKA
Priority:


Other Significant


Legal Authority:


43 USC 315; 43 USC 315a to 315r; 43 USC 1181d; 43 USC 1740


CFR Citation:


43 CFR 4100


Legal Deadline:


None


Abstract:


This rule will ensure that BLM documents its consideration of the 
social, cultural, environmental, and economic consequences of grazing 
changes; provide that changes in grazing use will be phased in under 
certain circumstances; allow BLM to share title with permittees and 
lessees to range improvements in certain circumstances; make clear how 
BLM will authorize grazing if a BLM decision affecting a grazing permit 
is stayed pending administratvive appeal; remove provisions in the 
present regulations concerning conservation use grazing permits; ensure 
adequate time for developing and successfully implementing an 
appropriate management action when BLM finds that rangelands do not 
meet standards and guidelines for rangeland health and that authorized 
grazing is a significant factor in not achieving one or more land 
health standards or not conforming with guidelines for grazing 
administration; and revise some administrative service charges.


Statement of Need:


This rulemaking is necessary to contribute to improving working 
relationships with permittees and lessees, protecting the health of the 
rangelands, and increasing administrative efficiency and effectiveness.


Summary of Legal Basis:


The primary laws that govern grazing on public land are the Taylor 
Grazing Act (TGA) of 1934, the Federal Land Policy and Management Act 
(FLPMA) of 1976, and the Public Rangelands Improvement Act (PRIA) of 
1978.


TGA directs that occupation and use of the range be regulated to 
preserve the land and its resources from destruction or unnecessary 
injury, and to provide for the orderly use, improvement, and 
development of the range. FLPMA provides authority and direction for 
managing the public lands on the basis of multiple use and sustained 
yield and mandates land use planning principles and procedures for the 
public lands. PRIA defines rangeland as public lands on which there is 
domestic livestock grazing or which are determined to be suitable for 
livestock grazing, establishes a national policy to improve the 
condition of public rangelands so they will become as productive as 
feasible for all rangeland values, requires a national inventory pf 
public rangeland conditions and trends, and authorizes funding for 
range improvement projects.


Alternatives:


The draft environmental impact statement (DEIS) on the proposed rule 
considered two alternatives in addition to the rule as proposed. The 
first alternative to the proposed rule considered in the DEIS was to 
continue to operate under the existing regulations. The existing 
regulations contain provisions that have been found unlawful by the 
Federal Courts. They also do too little to promote cooperation between 
BLM and grazing

[[Page 72775]]

permittees and lessees. They are also ambiguous at times and hard to 
understand.


The DEIS also considered a modified alternative with different 
approaches to several provisions in the proposed rule. BLM would have 
more discretion in phasing in changes in grazing use, be limited to 
five consecutive years in approving nonuse, and have discretion to use 
range assessments or monitoring or both to determine whether grazing 
management is achieving standards and conforming with guidelines. The 
alternative would include a prohibition of failing to comply with weed 
seed-free forage requirements, but would not include the current 
prohibition of failing to comply with Federal or State laws pertaining 
to resources.


In the early stages of planning this rule, BLM considered additional 
provisions such as Reserve Common Allotments for grazers to use when 
their allotments are unavailable due to fire, drought, or other 
factors, and authorizing grazers to lock gates on public lands 
temporarily. These provisions were dropped due to public comment on the 
advance notice of proposed rulemaking.


Anticipated Cost and Benefits:


BLM anticipates the following benefits: Increased livestock production 
as a result of increased forage productivity or increased ability to 
maintain grazing when it might otherwise be reduced; increased 
managerial flexibility, resulting in increased livestock output; 
improved environmental conditions; and potential changes in recreation 
values.


The major categories of costs include: BLM administrative costs 
(including enforcement and monitoring costs); compliance costs for 
permittees and lessees; environmental costs if the rule results in 
worsened environmental conditions.


The benefits and costs are thoroughly discussed in the Benefit-Cost/
Unfunded Mandates Act Analysis and Initial Regulatory Flexibility Act 
Analysis dated November 14, 2003, and available in the administrative 
record of the rule.


Risks:


As with any new rule, the public may at first misunderstand the changes 
in regulatory requirements. BLM will work with the public in 
implementing the rule and conduct outreach meetings to explain the rule 
as necessary.


There is also a risk that the monitoring requirements imposed by the 
rule may entail increased administrative costs and the need to 
reallocate administrative resources. We expect this risk to be 
minimized because of the thresholds in the regulations that must be 
crossed before monitoring is required.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           68 FR 9964                                     03/03/03
NPRM            68 FR 68452                                    12/08/03
NPRM Comment Period End                                        03/02/04
Final Action                                                   12/00/04
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None


Agency Contact:
Ted Hudson
Regulatory Analyst
Department of the Interior
Bureau of Land Management
Room 420
Regulatory Affairs Group (WO-630)
1849 C Street NW.
Washington, DC 20240
Phone: 202 452-5042
Fax: 202 653-5287
Email: [email protected]
RIN: 1004-AD42
BILLING CODE 4310-RK-S

[[Page 72776]]




DEPARTMENT OF JUSTICE (DOJ)



Statement of Regulatory Priorities
 The first and overriding priority of the Department of Justice is to 
prevent, detect, disrupt, and dismantle terrorism while preserving 
constitutional liberties. To fulfill this mission, the Department is 
devoting all the resources necessary and utilizing all legal 
authorities to eliminate terrorist networks, to prevent terrorist 
attacks, and to bring to justice those who kill Americans in the name 
of murderous ideologies. It is engaged in an aggressive arrest and 
detention campaign of lawbreakers with a single objective: To get 
terrorists off the street before they can harm more Americans. In 
addition to using investigative, prosecutorial, and other law 
enforcement activities, the Department is also using the regulatory 
process to enhance its ability to prevent future terrorist acts and 
safeguard our borders while ensuring that America remains a place of 
welcome to foreigners who come here to visit, work, or live peacefully. 
The Department also has wide-ranging responsibilities for criminal 
investigations, law enforcement, and prosecutions and, in certain 
specific areas, makes use of the regulatory process to better carry out 
the Department's law enforcement missions.
 The Department of Justice's regulatory priorities focus in particular 
on a major regulatory initiative in the area of civil rights. 
Specifically, the Department is planning to revise its regulations 
implementing titles II and III of the Americans With Disabilities Act. 
However, in addition to this specific initiative, several other 
components of the Department carry out important responsibilities 
through the regulatory process. Although their regulatory efforts are 
not singled out for specific attention in this regulatory plan, those 
components carry out key roles in implementing the Department's anti-
terrorism and law enforcement priorities.
Civil Rights
 The Department is planning to revise its regulations implementing 
titles II and III of the ADA to amend the ADA Standards for Accessible 
Design (28 CFR part 36, appendix A) to be consistent with the revised 
ADA accessibility guidelines published by the U.S. Architectural and 
Transportation Barriers Compliance Board (Access Board) in final form 
on July 23, 2004. (The Access Board had issued the guidelines in 
proposed form in November 1999 and in final draft form in April 2002.) 
Title II of the ADA prohibits discrimination on the basis of disability 
by public entities, and title III prohibits such discrimination by 
places of public accommodation and requires accessible design and 
construction of places of public accommodation and commercial 
facilities. In implementing these provisions, the Department of Justice 
is required by statute to publish regulations that include design 
standards that are consistent with the guidelines developed by the 
Access Board. The Access Board was engaged in a multiyear effort to 
revise and amend its accessibility guidelines. The goals of this 
project were: 1) To address issues such as unique State and local 
facilities (e.g., prisons, courthouses), recreation facilities, play 
areas, and building elements specifically designed for children's use 
that were not addressed in the initial guidelines; 2) to promote 
greater consistency between the Federal accessibility requirements and 
the model codes; and 3) to provide greater consistency between the ADA 
guidelines and the guidelines that implement the Architectural Barriers 
Act. The Access Board issued guidelines that address all of these 
issues. Therefore, to comply with the ADA requirement that the ADA 
standards remain consistent with the Access Board's guidelines, the 
Department will propose to adopt revised ADA Standards for Accessible 
Design that are consistent with the revised ADA Accessibility 
Guidelines.
 The Department also plans to review its regulations implementing title 
II and title III (28 CFR parts 35 and 36) to ensure that the 
requirements applicable to new construction and alterations under title 
II are consistent with those applicable under title III, to review and 
update the regulations to reflect the current state of law, and to 
ensure the Department's compliance with section 610 of the Small 
Business Regulatory Enforcement Fairness Act (SBREFA).
 The Department is planning to adopt and interpret the Access Board's 
revised and amended guidelines in three steps. The first step of the 
rulemaking process is an advance notice of proposed rulemaking, 
published in the Federal Register on September 30, 2004, at 69 FR 
58768, which the Department believes will simplify and clarify the 
preparation of the proposed rule to follow. In addition to giving 
notice of the proposed rule that will adopt revised ADA accessibility 
standards, the advance notice raises two sets of questions for public 
comment, and proposes a framework for the regulatory analysis that will 
accompany the proposed rule. One set of questions addresses 
interpretive matters related to adopting revised ADA accessibility 
standards, such as what should be the effective date of the revised 
standards and how best to apply the revised standards to existing 
facilities that have already complied with the current ADA standards. 
Another set of questions is directed to collecting data about the 
benefits and costs of applying the new standards to existing 
facilities. The second step of the rulemaking process will be a 
proposed rule proposing to adopt revised ADA accessibility standards 
consistent with the Access Board's revised and amended guidelines that 
will, in addition to revising the current ADA Standards for Accessible 
Design, supplement the standards with specifications for prisons, 
jails, court houses, legislative facilities, building elements designed 
for use by children, play areas, and recreation facilities. The 
proposed rule will also offer proposed answers to the interpretive 
questions raised in the advance notice and present an initial 
regulatory assessment; it will be followed by a final rule, the third 
step of the process. A separate part of the rulemaking process will be 
an advanced notice of proposed rulemaking seeking public comment on the 
section 610 review of the ADA regulations under SBREFA, with proposed 
and final rules to follow.
 The Department's revised and supplemented regulations under the ADA 
will affect small businesses, small governmental jurisdictions, and 
other small organizations (together, small entities). The Access Board 
has prepared regulatory assessments (including cost impact analyses) to 
accompany its new guidelines, which estimate the annual compliance 
costs that will be incurred by covered entities with regard to 
construction of new facilities. These assessments include the effect on 
small entities and will apply to new construction under the 
Department's revised and supplemented regulations. With respect to 
existing facilities, the Department will prepare an additional 
regulatory assessment of the estimated annual cost of compliance with 
regard to existing facilities. In this process, the Department will 
give careful consideration to the cost effects on small entities, 
including the solicitation of comments specifically designed to obtain 
compliance data relating to small entities.
Other Department Initiatives
1. Immigration Matters
 On March 1, 2003, pursuant to the Homeland Security Act of 2002 (HSA),

[[Page 72777]]

the responsibility for immigration enforcement and for providing 
immigration-related services and benefits such as naturalization and 
work authorization was transferred from the Justice Department's 
Immigration and Naturalization Service (INS) to the Department of 
Homeland Security (DHS). However, immigration judges and the Board of 
Immigration Appeals in the Executive Office for Immigration Review 
(EOIR)) remain part of the Department of Justice; the immigration 
judges adjudicate approximately 300,000 cases each year to determine 
whether the aliens should be ordered removed or should be granted some 
form of relief from removal. Accordingly, the Attorney General has a 
continuing role in the conduct of removal hearings, the granting of 
relief from removal, and the detention or release of aliens pending 
completion of removal proceedings. The Attorney General also is 
responsible for civil litigation and criminal prosecutions relating to 
the immigration laws.
 In several pending rulemaking actions, the Department is working to 
revise and update the regulations relating to removal proceedings in 
order to improve the efficiency and effectiveness of the hearings in 
resolving issues relating to removal of aliens and the granting of 
relief from removal.
1. Criminal
 Law Enforcement
 In large part, the Department's criminal law enforcement components do 
not rely on the rulemaking process to carry out their assigned 
missions. The Federal Bureau of Investigation (FBI), for example, is 
responsible for protecting and defending the United States against 
terrorist and foreign intelligence threats, upholding and enforcing the 
criminal laws of the United States, and providing leadership and 
criminal justice services to Federal, State, municipal, and 
international agencies and partners. Only in very limited contexts does 
the FBI rely on rulemaking.\1\ However, other components do make use of 
the rulemaking process in certain significant respects.
 The Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) issues 
regulations to enforce the Federal laws relating to the manufacture and 
commerce of firearms and explosives. ATF's mission and regulations are 
designed to:
 Curb illegal traffic in, and criminal use of, firearms, and to 
            assist State, local, and other Federal law enforcement 
            agencies in reducing crime and violence;
 Facilitate investigations of violations of Federal explosives 
            laws and arson-for-profit schemes;
 Regulate the firearms and explosives industries, including 
            systems for licenses and permits;
 Assure the collection of all National Firearms Act (NFA) 
            firearms taxes and obtain a high level of voluntary 
            compliance with all laws governing the firearms industry; 
            and
 Assist the States in their efforts to eliminate interstate 
            trafficking in, and the sale and distribution of, 
            cigarettes and alcohol in avoidance of Federal and State 
            taxes.
 ATF will continue, as a priority during fiscal year 2005, to seek 
modifications to its regulations governing commerce in explosives. ATF 
continues analysis of its regulations governing storage requirements 
for explosives, including fireworks explosive materials. ATF plans to 
issue final regulations implementing the provisions of the Safe 
Explosives Act, title XI, subtitle C, of Public Law 107-296, the 
Homeland Security Act of 2002 (enacted November 25, 2002).
 The Drug Enforcement Administration (DEA) is responsible for 
controlling abuse of narcotics and dangerous drugs, while ensuring 
adequate supplies for legitimate medical purposes, by regulating the 
aggregate supply of those drugs. However, now, the growing combination 
of drug trafficking and terrorism serves to call us even more urgently 
to action. DEA accomplishes its objectives through coordination with 
State, local, and other Federal officials in drug enforcement 
activities, development and maintenance of drug intelligence systems, 
regulation of legitimate controlled substances, and enforcement 
coordination and intelligence-gathering activities with foreign 
government agencies. DEA continues to develop and enhance regulatory 
controls relating to the diversion control requirements for controlled 
substances, as well as the requirements of the Comprehensive 
Methamphetamine Control Act of 1996 and the Methamphetamine Anti-
Proliferation Act of 2000, which regulate certain chemicals to prevent 
them from being diverted for the production of methamphetamine.
 The Federal Bureau of Prisons issues regulations to enforce the 
Federal laws relating to its mission: To protect society by confining 
offenders in the controlled environments of prisons and community-based 
facilities that are safe, humane, cost-efficient, and appropriately 
secure, and that provide work and other self-improvement opportunities 
to assist offenders in becoming law-abiding citizens. During the next 
12 months, in addition to other regulatory objectives aimed at 
accomplishing its mission, the Bureau will continue its ongoing efforts 
to: Reduce the introduction of contraband through various means (such 
as clarifying drug and alcohol surveillance testing programs); improve 
disciplinary procedures; and improve drug abuse treatment services.
Footnotes:
1. As one recent example, the FBI published a final rule in July 2004, 
amending regulations implementing the National Instant Criminal 
Background Check System (``NICS'') pursuant to the Brady Handgun 
Violence Prevention Act (``Brady Act''). This rule balanced the Brady 
Act's mandate that the Department protect legitimate privacy interests 
of law-abiding firearm transferees and the Department's obligation to 
enforce the Brady Act and the rest of the Gun Control Act and prevent 
prohibited persons from receiving firearms. Changes made by the final 
rule regarding the amount of time that the NICS retains information 
about approved firearm transfers in the system's chronological log of 
background check transactions (``Audit Log'') were required by section 
617 of H.R. 2673, the Fiscal Year 2004 Consolidated Appropriations 
bill, which was signed into law on January 23, 2004.
_______________________________________________________________________



DOJ--Civil Rights Division (CRT)

                              -----------

                             PRERULE STAGE

                              -----------




86. NONDISCRIMINATION ON THE BASIS OF DISABILITY IN PUBLIC 
ACCOMMODATIONS AND COMMERCIAL FACILITIES (SECTION 610 REVIEW)
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


5 USC 301; 28 USC 509; 28 USC 510; 42 USC 12186(b)


CFR Citation:


28 CFR 36

[[Page 72778]]

Legal Deadline:


None


Abstract:


In 1991, the Department of Justice published regulations to implement 
title III of the Americans With Disabilities Act of 1990 (ADA). Those 
regulations include the ADA Standards for Accessible Design, which 
establish requirements for the design and construction of accessible 
facilities that are consistent with the ADA Accessibility Guidelines 
(ADAAG) published by the U.S. Architectural and Transportation Barriers 
Compliance Board (Access Board). In the time since the regulations 
became effective, the Department of Justice and the Access Board have 
each gathered a great deal of information regarding the implementation 
of the Standards. The Access Board began the process of revising ADAAG 
a number of years ago. It published new ADAAG in final form on July 23, 
2004, after having published guidelines in proposed form in November 
1999 and in draft final form in April 2002. In order to maintain 
consistency between ADAAG and the ADA Standards, the Department is 
reviewing its title III regulations and expects to propose, in one or 
more stages, to adopt revised ADA Standards consistent with the final 
revised ADAAG and to make related revisions to the Department's title 
III regulations. In addition to maintaining consistency between ADAAG 
and the Standards, the purpose of this review and these revisions will 
be to more closely coordinate with voluntary standards; to clarify 
areas which, through inquiries and comments to the Department's 
technical assistance phone lines, have been shown to cause confusion; 
to reflect evolving technologies in areas affected by the Standards; 
and to comply with section 610 of the Regulatory Flexibility Act, which 
requires agencies once every 10 years to review rules that have a 
significant economic impact upon a substantial number of small 
entities.


The first step in adopting revised Standards is an advance notice of 
proposed rulemaking that was published in the Federal Register on 
September 30, 2004, at 69 FR 58768, issued under both title II and 
title III. The Department believes that the advance notice will 
simplify and clarify the preparation of the proposed rule to follow. In 
addition to giving notice that the proposed rule will adopt revised ADA 
accessibility standards, the advance notice raises questions for public 
comment and proposes a framework for the regulatory analysis that will 
accompany the proposed rule.


The adoption of revised ADAAG will also serve to address changes to the 
ADA Standards previously proposed in RIN 1190-AA26, RIN 1190-AA38, RIN 
1190-AA47, and RIN 1190-AA50, all of which have now been withdrawn from 
the Unified Agenda. These changes will include technical specifications 
for facilities designed for use by children, accessibility standards 
for State and local government facilities, play areas, and recreation 
facilities, all of which had previously been published by the Access 
Board.


The timetable set forth below refers to the notice of proposed 
rulemaking that the Department will issue as the second step of the 
above described title III rulemaking. This notice of proposed 
rulemaking will be issued under both title II and title III. For 
purposes of the title III regulation, this notice will propose to adopt 
revised ADA Standards for Accessible Design consistent with the minimum 
guidelines of the revised ADAAG. The second stage will initiate the 
review of the regulation in accordance with the requirements of section 
610 of the Regulatory Flexibility Act, as amended by the Small Business 
Regulatory Enforcement Fairness Act of 1996 (SBREFA).


Statement of Need:


Section 504 of the ADA requires the Access Board to issue supplemental 
minimum guidelines and requirements for accessible design of buildings 
and facilities subject to the ADA, including title III. Section 306(c) 
of the ADA requires the Attorney General to promulgate regulations 
implementing title III that are consistent with the Access Board's ADA 
guidelines. Because this rule will adopt standards that are consistent 
with the minimum guidelines issued by the Access Board, this rule is 
required by statute. Similarly, the Department's review of its title 
III regulation is being undertaken to comply with the requirements of 
the Regulatory Flexibility Act, as amended by SBREFA.


Summary of Legal Basis:


The summary of the legal basis of authority for this regulation is set 
forth above under Legal Authority and Statement of Need.


Alternatives:


The Department is required by the ADA to issue this regulation. 
Pursuant to SBREFA, the Department's title III regulation will consider 
whether alternatives to the currently published requirements are 
appropriate.


Anticipated Cost and Benefits:


The Access Board has analyzed the effect of applying its proposed 
amendments to ADAAG to entities covered by titles II and III of the ADA 
and has determined that they constitute a significant regulatory action 
for purposes of Executive Order 12866. The Access Board's determination 
will apply as well to the revised ADA standards published by the 
Department. The Department's proposed procedural amendments will not 
have a significant impact on small entities.


As part of its revised ADAAG, the Access Board made available in 
summary form an updated regulatory assessment to accompany the final 
revised ADAAG. The Access Board's regulatory assessment will also apply 
to the Department's proposed adoption of revised ADAAG as ADA standards 
insofar as the standards apply to new construction and alteration. The 
Department will also prepare an additional regulatory assessment of the 
estimated annual cost of compliance with the revised standards with 
regard to existing facilities.


Risks:


Without the proposed changes to the Department's title III regulation, 
the ADA Standards will fail to be consistent with the ADAAG.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           69 FR 58768                                    09/30/04
ANPRM Comment Period End                                       01/28/05
NPRM                                                           07/00/05
NPRM Comment Period End                                        10/00/05
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses, Organizations


Government Levels Affected:


None


Additional Information:


RIN 1190-AA44, which will effect changes to 28 CFR 36 (the Department's 
regulation implementing title III of the ADA), is related to another 
rulemaking of the Civil Rights Division, RIN 1190-AA46, which will 
effect changes to 28

[[Page 72779]]

CFR 35 (the Department's regulation implementing title II of the ADA).


Agency Contact:
John L. Wodatch
Chief, Disability Rights Section
Department of Justice
Civil Rights Division
P.O. Box 66738
Washington, DC 20035
Phone: 800 514-0301
TDD Phone: 800 514-0383
Fax: 202 307-1198
RIN: 1190-AA44
_______________________________________________________________________



DOJ--CRT



87. NONDISCRIMINATION ON THE BASIS OF DISABILITY IN STATE AND LOCAL 
GOVERNMENT SERVICES (SECTION 610 REVIEW)
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


5 USC 301; 28 USC 509 to 510; 42 USC 12134; PL 101-336


CFR Citation:


28 CFR 35


Legal Deadline:


None


Abstract:


On July 26, 1991, the Department published its final rule implementing 
title II of the Americans With Disabilities Act (ADA). On November 16, 
1999, the U.S. Architectural and Transportation Barriers Compliance 
Board (Access Board) issued its first comprehensive review of the ADA 
Accessibility Guidelines, which form the basis of the Department's ADA 
Standards for Accessible Design. The Access Board published an 
Availability of Draft Final Guidelines on April 2, 2002, and published 
the ADA Accessibility Guidelines in final form on July 23, 2004. The 
ADA (section 204(c)) requires the Department's standards to be 
consistent with the Access Board's guidelines. In order to maintain 
consistency between ADAAG and the Standards, the Department is 
reviewing its title II regulations and expects to propose, in one or 
more stages, to adopt revised standards consistent with new ADAAG. The 
Department will also, in one or more stages, review its title II 
regulations for purposes of section 610 of the Regulatory Flexibility 
Act and make related changes to its title II regulations.


In addition to the statutory requirement for the rule, the social and 
economic realities faced by Americans with disabilities dictate the 
need for the rule. Individuals with disabilities cannot participate in 
the social and economic activities of the Nation without being able to 
access the programs and services of State and local governments. 
Further, amending the Department's ADA regulations will improve the 
format and usability of the ADA Standards for Accessible Design; 
harmonize the differences between the ADA Standards and national 
consensus standards and model codes; update the ADA Standards to 
reflect technological developments that meet the needs of persons with 
disabilities; and coordinate future ADA Standards revisions with 
national standards and model code organizations. As a result, the 
overarching goal of improving access for persons with disabilities so 
that they can benefit from the goods, services, and activities provided 
to the public by covered entities will be met.


The first part of the rulemaking process is an advance notice of 
proposed rulemaking, published in the Federal Register on September 30, 
2004, at 69 FR 58768, issued under both title II and title III. The 
Department believes the advance notice will simplify and clarify the 
preparation of the proposed rule to follow. In addition to giving 
notice of the proposed rule that will adopt revised ADA accessibility 
standards, the advance notice raises questions for public comment and 
proposes a framework for the regulatory analysis that will accompany 
the proposed rule.


The adoption of revised ADA Standards consistent with revised ADAAG 
will also serve to address changes to the ADA Standards previously 
proposed under RIN 1190-AA26, RIN 1190-AA38, RIN 1190-AA47, and RIN 
1190-AA50, all of which have now been withdrawn from the Unified 
Agenda. These changes will include technical specifications for 
facilities designed for use by children, accessibility standards for 
State and local government facilities, play areas, and recreation 
facilities, all of which had previously been published by the Access 
Board.


The timetable set forth below refers to the notice of proposed 
rulemaking that the Department will issue as the second step of the 
above-described title II rulemaking. This notice of proposed rulemaking 
will be issued under both title II and title III. For purposes of the 
title II regulation alone, this notice will also propose to eliminate 
the Uniform Federal Accessibility Standards (UFAS) as an alternative to 
the ADA Standards for Accessible Design.


Statement of Need:


Section 504 of the ADA requires the Access Board to issue supplemental 
minimum guidelines and requirements for accessible design of buildings 
and facilities subject to the ADA, including title II. Section 204(c) 
of the ADA requires the Attorney General to promulgate regulations 
implementing title II that are consistent with the Access Board's ADA 
guidelines. Because this rule will adopt standards that are consistent 
with the minimum guidelines issued by the Access Board, this rule is 
required by statute. Similarly, the Department's review of its title II 
regulations is being undertaken to comply with the requirements of the 
Regulatory Flexibility Act, as amended by the Small Business Regulatory 
Enforcement Fairness Act (SBREFA).


Summary of Legal Basis:


The summary of the legal basis of authority for this regulation is set 
forth above under Legal Authority and Statement of Need.


Alternatives:


The Department is required by the ADA to issue this regulation as 
described in the Statement of Need above. Pursuant to SBREFA, the 
Department's title II regulation will consider whether alternatives to 
the currently published requirements are appropriate.


Anticipated Cost and Benefits:


The Administration is deeply committed to ensuring that the goals of 
the ADA are met. Promulgating this amendment to the Department's ADA 
regulations will ensure that entities subject to the ADA will have one 
comprehensive regulation to follow. Currently, entities subject to 
title II of the ADA (State and local governments) have a choice between 
following the Department's ADA Standards for title III, which were 
adopted for places of public accommodation and commercial facilities 
and which do not contain standards for common State and local 
government buildings (such as courthouses and prisons), or the Uniform 
Federal Accessibility Standards (UFAS). By developing one comprehensive 
standard, the Department will eliminate the confusion that arises when 
governments try to mesh two different standards. As a result, the 
overarching goal of improving access to persons with disabilities will 
be better served.

[[Page 72780]]

The Access Board has analyzed the effect of applying its proposed 
amendments to ADAAG to entities covered by titles II and III of the ADA 
and has determined that they constitute a significant regulatory action 
for purposes of Executive Order 12866. The Access Board's determination 
will apply as well to the revised ADA Standards published by the 
Department. The Department's proposed procedural amendments will not 
have a significant impact on small entities.


As part of its revised ADAAG, the Access Board made available in 
summary form an updated regulatory assessment to accompany the final 
revised ADAAG. The Access Board's regulatory assessment will also apply 
to the Department's proposed adoption of revised ADAAG as ADA standards 
insofar as the standards apply to new construction and alteration. The 
Department will also prepare an additional regulatory assessment of the 
estimated annual cost of compliance with the revised standards with 
regard to existing facilities.


The Access Board has made every effort to lessen the impact of its 
proposed guidelines on State and local governments but recognizes that 
the guidelines will have some federalism effects. These affects are 
discussed in the Access Board's regulatory assessment, which also 
applies to the Department's proposed rule.


Risks:


Without this amendment to the Department's ADA regulations, regulated 
entities will be subject to confusion and delay as they attempt to sort 
out the requirements of conflicting design standards. This amendment 
should eliminate the costs and risks associated with that process.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           69 FR 58768                                    09/30/04
ANPRM Comment Period End                                       01/28/05
NPRM                                                           07/00/05
NPRM Comment Period End                                        10/00/05
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


 Governmental Jurisdictions


Government Levels Affected:


Local, State


Federalism:


 This action may have federalism implications as defined in EO 13132.


Additional Information:


RIN 1190-AA46, which will effect changes to 28 CFR 35 (the Department's 
regulation implementing title II of the ADA), is related to another 
rulemaking of the Civil Rights Division, RIN 1190-AA44, which will 
effect changes to 28 CFR 36 (the Department's regulation implementing 
title III of the ADA). By adopting revised ADAAG, this rulemaking will, 
among other things, address changes to the ADA Standards previously 
proposed in RINs 1190-AA26, 1190-AA36, and 1190-AA38, which have been 
withdrawn and merged into this rulemaking. These changes include 
accessibility standards for State and local government facilities that 
had been previously published by the Access Board (RIN 1190-AA26) and 
the timing for the compliance of State and local governments with the 
curb-cut requirements of the title II regulation (RIN 1190-AA36). In 
order to consolidate regulatory actions implementing title II of the 
ADA, on February 15, 2000, RINs 1190-AA26 and 1190-AA38 were merged 
into this rulemaking and on March 5, 2002, RIN 1190-AA36 was merged 
into this rulemaking.


Agency Contact:
John L. Wodatch
Chief, Disability Rights Section
Department of Justice
Civil Rights Division
P.O. Box 66738
Washington, DC 20035
Phone: 800 514-0301
TDD Phone: 800 514-0383
Fax: 202 307-1198
RIN: 1190-AA46
BILLING CODE 4410-BP-S

[[Page 72781]]




DEPARTMENT OF LABOR (DOL)



DEPARTMENT OF LABOR (DOL)
2004 Regulatory Plan
Executive Summary: Protecting America's Workers
Since its creation in 1913, the Department of Labor has been guided by 
the idea that workers deserve safe and healthy workspaces, as well as 
protection of their wages and pensions. Protecting America's workers is 
a top priority of the Secretary of Labor. The Department works to 
enforce laws and regulations to ensure the health and safety of the 
American workforce. The vast majority of employers work hard to keep 
their employees and workplaces safe and secure. DOL also strives to 
provide employers with the knowledge and tools they need to carry out 
their legal obligations. The Secretary has made protecting workers 
through the coupling of compliance assistance and tough enforcement one 
of her top priorities. Her compliance assistance initiative is based on 
the proven success that comes when government, employers, unions and 
employees work together.
Compliance assistance works to prevent injuries. Educating and 
encouraging employers helps workers far more than enforcement alone, 
since no enforcement process can possibly identify every violation of 
the law, and fines and penalties can never fully redress losses of 
life, health, and economic well-being.
The Department is committed to aggressively enforcing the laws that 
protect employees, including the rights of workers returning to their 
jobs after military service. Workers also need information about 
protection of their health insurance and pension benefits. In addition, 
DOL has responsibilities beyond worker protection. The Department 
recognizes that workers need constant updating of skills to compete in 
a changing marketplace. DOL helps employers and workers bridge the gap 
between the requirements of new high-technology jobs and the skills of 
the workers who are needed to fill them.
The Secretary of Labor's Regulatory Plan for Accomplishing These 
Objectives
In general, DOL tries to help employees and employers meet their needs 
in a cooperative fashion. DOL will maintain health and safety standards 
and protect employees by working with the regulated community.
DOL considers the following proposals to be proactive, common sense 
approaches to the issues most clearly needing regulatory attention.
The Department's Regulatory Priorities
DOL has identified 16 high priority items for regulatory action. Six 
items address health and safety issues, which are central to DOL's 
mission and which represent a major focus of the Secretary. Two 
agencies, the Mine Safety and Health Administration (MSHA) and the 
Occupational Safety and Health Administration (OSHA), are responsible 
for these initiatives.
MSHA administers the Federal Mine Safety and Health Act of 1977 (Mine 
Act). The agency is committed to ensuring safer and healthier 
workplaces for the nation's miners in a number of ways, and will 
continue to concentrate on improving existing health standards and 
addressing emerging health hazards in mining.
MSHA is considering lowering the existing permissible exposure limit 
(PEL) for asbestos at metal and nonmetal and coal mines, to reduce the 
risk of asbestos-related death and disease among miners. MSHA also is 
considering specifying criteria for the method used for sample analysis 
(RIN 1219-AB24). MSHA published an advance notice of proposed 
rulemaking (ANPRM) and conducted a series of public meetings in 2002 to 
allow early participation by interested parties in the rulemaking. MSHA 
is preparing a proposed rule that fully considers comments received in 
response to the ANPRM, testimony at the public meeting, current 
scientific evidence, and the experience of other agencies.
MSHA also continues its rulemaking on Diesel Particulate Matter 
Exposure of Underground Metal and Nonmetal Miners (RIN 1219-AB29). A 
proposed rule was published in August 2003. MSHA will address several 
provisions in the final standard, including changing the diesel 
particulate matter surrogate from total carbon to elemental carbon for 
the interim and limit changing the interim limit concentration-based 
limit to a personal exposure limit (PEL) establishing the hierarchy of 
controls that MSHA applies to metal and nonmetal mines pursuant to its 
enforcement policy for exposure-based health standards, allowing 
Personal Protective Equipment (PPE), and addressing the diesel 
particulate matter control plan.
The Occupational Safety and Health Administration oversees a wide range 
of measures in the public and private sectors. OSHA is committed to 
establishing clear and sensible priorities, and to continuing to reduce 
occupational deaths, injuries, and illnesses.
OSHA's high-priority initiatives address health standards. The first, a 
revision to the Respiratory Protection Standard, will address Assigned 
Protection Factors for different types of respirators (RIN 1218-AA05). 
This action will improve respiratory protection for employees required 
to wear respirators and will make it easier for employers to choose the 
appropriate respirator for a given task. OSHA published an NPRM on June 
6, 2003, and informal public hearings were held on January 28-30, 2004.
OSHA's second initiative in the area of health standards addresses 
worker exposures to crystalline silica (RIN 1218-AB70). This substance 
is one of the most widely found in workplaces and data indicate that 
exposure to it may cause silicosis, a debilitating respiratory disease, 
and perhaps cancer as well. OSHA has obtained input from small 
businesses about regulatory approaches through a Small Business 
Regulatory Enforcement Fairness Act (SBREFA) panel, and the Panel 
report was submitted to the Assistant Secretary of OSHA on December 19, 
2003. OSHA is currently preparing a risk assessment and plans to 
complete an external peer review of a draft assessment by February 
2005. This rule was discussed in the 2002 OMB Report to Congress on the 
Costs and Benefits of Regulations.
OSHA's third health initiative addresses worker exposure to hexavalent 
chromium (RIN 1218-AB45). Approximately 380,000 workers are exposed to 
this substance in general industry, maritime, construction and 
agriculture. Exposure to hexavalent chromium is associated with lung 
cancer and dermatoses. OSHA has obtained input from small businesses 
about regulatory approaches through a Small Business Regulatory 
Enforcement Fairness Act (SBREFA) panel, and the Panel report was 
submitted to the Assistant Secretary of OSHA on April 20, 2004. The 
proposed rule was published on October 4, 2004. This standard was 
discussed in OMB's 2002 Report to Congress on the Costs and Benefits of 
Regulation.
The fourth health initiative, OSHA's Standards Improvement Project, 
will streamline a number of health standards by removing language that 
is outdated, duplicative, unnecessary or inconsistent (RIN 1218-AB81). 
These changes will reduce the time and effort needed to

[[Page 72782]]

understand and comply with these standards. An NPRM was published 
October 31, 2002. A hearing was held in July 2003, and a final rule has 
been prepared.
Protection of pension and health benefits continues to be a priority of 
the Secretary of Labor. Consistent with the Secretary's priorities for 
FY 2005, the Employee Benefits Security Administration (EBSA) will 
focus on compliance assistance for pension and group health plans 
through issuance of guidance. Specific initiatives for group health 
plans include guidance on the application of the Health Insurance 
Portability and Accountability Act (HIPAA) access, portability and 
renewability provisions (RIN 1210-AA54); and the HIPAA 
nondiscrimination provisions of the Employee Retirement Income Security 
Act (ERISA) (RIN 1210-AA77). With respect to pension plans, the 
Department will focus on establishing a safe harbor under which 
employers will be treated as having made timely deposits of participant 
contributions in their 401(k) plan (RIN 1210-AB02). The Department also 
will focus on the development of guidance that will facilitate the 
payment of benefits from 401(k) and other defined contribution plans 
that have been abandoned by their sponsors (RIN 1210-AA97).
ERISA's requirements affect an estimated 730,000 private sector 
employee pension benefit plans (covering approximately 99 million 
participants); an estimated 2.5 million group health benefit plans 
(covering 131 million participants and dependents); and 3.4 million 
other welfare benefits plans (covering approximately 190 million 
participants).
The Secretary's emphasis on meeting the needs of the 21st century 
workforce is reflected in the plan of the Employment and Training 
Administration (ETA) to issue regulations reflecting recent changes to 
the Trade Adjustment Assistance (TAA) program, as enacted in the Trade 
Act of 2002. The regulations will be issued in two parts: regulations 
covering TAA program benefits (RIN 1205-AB32), and regulations covering 
petition filing, investigations and the new Alternative TAA Program for 
Older Workers (RIN 1205-AB40). The proposed rules would address the 
many new features of the TAA program: consolidation of the TAA and 
NAFTA-TAA programs; rapid response services for workers to facilitate 
more rapid reemployment; expanded eligibility; increased benefits, 
including health care insurance assistance; and Alternative TAA for 
Older Workers program. The new regulations will be written in plain 
English, making them easier to read and use.
In its second initiative, ETA proposes to re-engineer the permanent 
labor certification process (RIN 1205-AA66). ETA's goals are to make 
fundamental changes that will streamline the process, save resources, 
improve the effectiveness of the program, and better serve the 
Department of Labor's customers. This rule was discussed in the 2002 
OMB Report to Congress on the Costs and Benefits of Regulations.
The Employment Standards Administration (ESA) has set forth two 
priority regulatory initiatives. ESA's first initiative updates the 
child labor rules issued under the Fair Labor Standards Act (FLSA) to 
address changes in the nature of the workplace and situations in which 
minors may operate certain kinds of machinery (RIN 1215-AA09). While 
young workers need employment experiences that will help them gain the 
skills needed to find and hold good jobs later in life, they also need 
to focus on obtaining a high-quality education, and the assurance that 
their work hours are reasonable will help them in doing so.
ESA's second initiative pertains to regulations issued under the Family 
and Medical Leave Act (FMLA) that were also discussed in OMB's 2001 and 
2002 Reports to Congress on the Costs and Benefits of Regulations. 
Revisions will be proposed to the FMLA's implementing regulations to 
address issues raised by the decision of the U.S. Supreme Court in 
Ragsdale v. Wolverine World Wide, Inc., 122 S. Ct. 1155 (2002), and the 
decisions of other courts.
Finally, the Secretary 's commitment to protecting the employment 
rights of service members as they return to the civilian workforce is 
reflected by the Veterans' Employment and Training Service's (VETS) 
initiative to promulgate regulations implementing the Uniformed 
Services Employment and Reemployment Rights Act of 1994 (USERRA). 
USERRA provides employment and reemployment protections for members of 
the uniformed services, including veterans and members of the Reserve 
and National Guard. The Department has not previously issued 
implementing regulations under USERRA. Authoritative written guidance 
interpreting USERRA will ensure that our service members serve secure 
in the knowledge that they will be able to return to their jobs with 
the same pay, benefits, and status they would have attained had they 
not been away on military duty.
_______________________________________________________________________



DOL--Employment Standards Administration (ESA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




88. FAMILY AND MEDICAL LEAVE ACT OF 1993; CONFORM TO THE SUPREME 
COURT'S RAGSDALE DECISION
Priority:


Other Significant


Unfunded Mandates:


Undetermined


Legal Authority:


29 USC 2654


CFR Citation:


29 CFR 825


Legal Deadline:


None


Abstract:


The U.S. Supreme Court, in Ragsdale v. Wolverine World Wide, Inc., 122 
S. Ct. 1155 (2002), invalidated regulatory provisions issued under the 
Family and Medical Leave Act (FMLA) pertaining to the effects of an 
employer's failure to timely designate leave that is taken by an 
employee as being covered by the FMLA. The Department intends to 
propose revisions to the FMLA regulations to address issues raised by 
this and other judicial decisions.


Statement of Need:


The FMLA requires covered employers to grant eligible employees up to 
12 workweeks of unpaid, job-protected leave a year for specified family 
and medical reasons, and to maintain group health benefits during the 
leave as if the employees continued to work instead of taking leave. 
When an eligible employee returns from FMLA leave, the employer must 
restore the employee to the same or an equivalent job with equivalent 
pay, benefits, and other conditions of employment. FMLA makes it 
unlawful for an employer to interfere with, restrain, or deny the 
exercise of any right provided by the FMLA.


The FMLA regulations require employers to designate if an employee's 
use of leave is counting against the employee's FMLA leave entitlement,

[[Page 72783]]

and to notify the employee of that designation (29 CFR section 
825.208). Section 825.700(a) of the regulations provides that if an 
employee takes paid or unpaid leave and the employer does not designate 
the leave as FMLA leave, the leave taken does not count against the 
employee's 12 weeks of FMLA leave entitlement.


On March 19, 2002, the U.S. Supreme Court issued its decision in 
Ragsdale v. Wolverine World Wide, Inc., 122 S. Ct. 1155 (2002). In that 
decision, the Court invalidated regulatory provisions pertaining to the 
effects of an employer's failure to timely designate leave that is 
taken by an employee as being covered by the FMLA. The Court ruled that 
29 CFR section 825.700(a) was invalid absent evidence that the 
employer's failure to designate the leave as FMLA leave interfered with 
the employee's exercise of FMLA rights. This proposed rule is being 
prepared to address issues raised by this and other judicial decisions.


Summary of Legal Basis:


This rule is issued pursuant to section 404 of the Family and Medical 
Leave Act, 29 U.S.C. section 2654.


Alternatives:


After completing a review and analysis of the Supreme Court's decision 
in Ragsdale and other judicial decisions, regulatory alternatives will 
be developed for notice-and-comment rulemaking.


Anticipated Cost and Benefits:


The costs and benefits of this rulemaking action are not expected to 
exceed $100 million per year or otherwise trigger economic significance 
under Executive Order 12866.


Risks:


This rulemaking action does not directly affect risks to public health, 
safety, or the environment.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           03/00/05
NPRM Comment Period End                                        05/00/05
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


 Businesses, Governmental Jurisdictions, Organizations


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Agency Contact:
Alfred B. Robinson
Acting Administrator, Wage and Hour Division
Department of Labor
Employment Standards Administration
200 Constitution Avenue NW.
FP Building
S3502
Washington, DC 20210
Phone: 202 693-0051
Fax: 202 693-1302
RIN: 1215-AB35
_______________________________________________________________________



DOL--ESA

                              -----------

                            FINAL RULE STAGE

                              -----------




89. CHILD LABOR REGULATIONS, ORDERS, AND STATEMENTS OF INTERPRETATION 
(ESA/W-H)
Priority:


Other Significant


Legal Authority:


29 USC 203(l)


CFR Citation:


29 CFR 570


Legal Deadline:


None


Abstract:


Section 3(l) of the Fair Labor Standards Act requires the Secretary of 
Labor to issue regulations with respect to minors between 14 and 16 
years of age ensuring that the periods and conditions of their 
employment do not interfere with their schooling, health, or well-
being. The Secretary is also directed to designate occupations that are 
particularly hazardous for minors 16 and 17 years of age. Child Labor 
Regulation No. 3 sets forth the permissible industries and occupations 
in which 14- and 15-year-olds may be employed, and specifies the number 
of hours in a day and in a week, and time periods within a day, that 
such minors may be employed. The Department has invited public comment 
in considering whether changes in technology in the workplace and job 
content over the years require new hazardous occupation orders, and 
whether changes are needed in some of the applicable hazardous 
occupation orders. Comment has also been solicited on whether revisions 
should be considered in the permissible hours and time-of-day standards 
for 14- and 15-year-olds. Comment has been sought on appropriate 
changes required to implement school-to-work transition programs. 
Additionally, Congress enacted Public Law 104-174 (August 6, 1996), 
which amended FLSA section 13(c) and requires changes in the 
regulations under Hazardous Occupation Order No. 12 regarding power-
driven paper balers and compactors, to allow 16- and 17-year-olds to 
load, but not operate or unload, machines meeting applicable American 
National Standards Institute (ANSI) safety standards and certain other 
conditions. Congress also passed the Drive for Teen Employment Act, 
Public Law 105-334 (October 31, 1998), which prohibits minors under age 
17 from driving automobiles and trucks on public roads on the job and 
sets criteria for 17-year-olds to drive such vehicles on public roads 
on the job.


Statement of Need:


Because of changes in the workplace and the introduction of new 
processes and technologies, the Department is undertaking a 
comprehensive review of the regulatory criteria applicable to child 
labor. Other factors necessitating a review of the child labor 
regulations are changes in places where young workers find employment 
opportunities, the existence of differing Federal and State standards, 
and the divergent views on how best to correlate school and work 
experiences.


Under the Fair Labor Standards Act, the Secretary of Labor is directed 
to provide by regulation or by order for the employment of youth 
between 14 and 16 years of age under periods and conditions which will 
not interfere with their schooling, health and well-being. The 
Secretary is also directed to designate occupations that are 
particularly hazardous for youth between the ages of 16 and 18 years or 
detrimental to their health or well-being. The Secretary has done so by 
specifying, in regulations, the permissible industries and occupations 
in which 14- and 15-year-olds may be employed, and the number of hours 
per day and week and the time periods within a day in which they may be 
employed. In addition, these regulations designate the occupations 
declared particularly hazardous for minors between 16 and 18 years of 
age or detrimental to their health or well-being.


Public comment has been invited in considering whether changes in

[[Page 72784]]

technology in the workplace and job content over the years require new 
hazardous occupation orders or necessitate revision to some of the 
existing hazardous orders. Comment has also been invited on whether 
revisions should be considered in the permissible hours and time-of-day 
standards for the employment of 14- and 15-year-olds, and whether 
revisions should be considered to facilitate school-to-work transition 
programs. When issuing the regulatory proposals (after review of public 
comments on the advance notice of proposed rulemaking), the 
Department's focus was on assuring healthy, safe and fair workplaces 
for young workers, and at the same time promoting job opportunities for 
young people and making regulatory standards less burdensome to the 
regulated community.


The Department will also be considering what additional revisions to 
the hazardous occupation orders will be undertaken to address 
recommendations of the National Institute for Occupational Safety and 
Health in its May 2002 report to the Department.


Summary of Legal Basis:


These regulations are issued under sections 3(l), 11, 12, and 13 of the 
Fair Labor Standards Act, 29 U.S.C. sections 203(l), 211, 212, and 213 
which require the Secretary of Labor to issue regulations prescribing 
permissible time periods and conditions of employment for minors 
between 14 and 16 years old so as not to interfere with their 
schooling, health, or well-being, and to designate occupations that are 
particularly hazardous or detrimental to the health or well-being of 
minors under 18 years old.


Alternatives:


Regulatory alternatives developed based on recent legislation and the 
public comments responding to the advance notice of proposed rulemaking 
included specific proposed additions or modifications to the paper 
baler, teen driving, explosive materials, and roofing hazardous 
occupation orders, and proposed changes to the permissible cooking 
activities that 14- and 15-year-olds may perform in retail 
establishments.


Anticipated Cost and Benefits:


Preliminary estimates of the anticipated costs and benefits of this 
regulatory action indicated that the rule was not economically 
significant. Benefits will include safer working environments and the 
avoidance of injuries with respect to young workers.


Risks:


The child labor regulations, by ensuring that permissible job 
opportunities for working youth are safe and healthy and not 
detrimental to their education as required by the statute, produce 
positive benefits by reducing health and productivity costs employers 
may otherwise incur from higher accident and injury rates to young and 
inexperienced workers. Given the limited nature of the changes in the 
proposed rule, a detailed assessment of the magnitude of risk was not 
prepared.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Final Rule      56 FR 58626                                    11/20/91
Final Rule Effective                                           12/20/91
ANPRM           59 FR 25167                                    05/13/94
ANPRM Comment Pe59 FR 40318                                    08/11/94
NPRM            64 FR 67130                                    11/30/99
NPRM Comment Period End                                        01/31/00
Final Action                                                   12/00/04
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None


Agency Contact:
Alfred B. Robinson
Acting Administrator, Wage and Hour Division
Department of Labor
Employment Standards Administration
200 Constitution Avenue NW.
FP Building
S3502
Washington, DC 20210
Phone: 202 693-0051
Fax: 202 693-1302
RIN: 1215-AA09
_______________________________________________________________________



DOL--Employment and Training Administration (ETA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




90. REVISION TO THE DEPARTMENT OF LABOR BENEFIT REGULATIONS FOR TRADE 
ADJUSTMENT ASSISTANCE FOR WORKERS UNDER THE TRADE ACT OF 1974, AS 
AMENDED
Priority:


Other Significant


Legal Authority:


19 USC 2320; Secretary's Order No. 3-81, 46 FR 31117


CFR Citation:


29 CFR 90; 20 CFR 617; 20 CFR 618; 20 CFR 665; 20 CFR 671; . . .


Legal Deadline:


None


Abstract:


The Trade Adjustment Assistance Reform Act of 2002, enacted on August 
6, 2002, contains provisions amending title 2, chapter 2 of the Trade 
Act of 1974, entitled Adjustment Assistance for Workers. The 
amendments, effective 90 days from enactment (November 4, 2002), make 
additions to where and by whom a petition may be filed, expand 
eligibility to workers whose production has been shifted to certain 
foreign countries and to worker groups secondarily affected, and make 
substantive changes regarding trade adjustment assistance (TAA) program 
benefits.


It is the agency's intention to create a new 20 CFR part 618 to 
incorporate the amendments and write it in plain English, while 
amending the WIA regulations at 20 CFR parts 665 and 671 regarding 
Rapid Response and National Emergency Grants as they relate to the TAA 
program.


The proposed part 618 consists of nine subparts: subpart A - General; 
subpart B--Petitions and Determinations of Eligibility to Apply for 
Trade Adjustment Assistance (and Alternative TAA); subpart C---Delivery 
of Services throughout the One-Stop Delivery System; subpart D--Job 
Search Allowances; subpart E--Relocation Allowances; subpart F--
Training Services; subpart G--Trade Readjustment Allowances (TRA); 
subpart H--Administration by Applicable State Agencies; and subpart I--
Alternative Trade Adjustment Assistance for Older Workers. Because of 
the complexity of the subject matter and the States' needs for 
definitive instructions on providing TAA benefits, the rulemaking for 
part 618 is divided into two parts. This notice of proposed rulemaking 
covers the general provisions (subpart A) and TAA benefits portions 
(subpart C through subpart H) of the regulations. A separate notice of 
proposed rulemaking will cover the two remaining subparts (subpart B 
and subpart I).

[[Page 72785]]

Statement of Need:


The Trade Adjustment Assistance Reform Act of 2002, enacted August 6, 
2002, repeals the North American Free Trade Agreement-Transitional 
Adjustment Assistance provisions for workers affected by the NAFTA 
Implementation Act and adds significant amendments to worker benefits 
under Trade Adjustment Assistance for Workers, as provided for in the 
Trade Act of 1974.


The 2002 Trade Act amends where and by whom a petition may be filed. 
Program benefits for TAA eligible recipients are expanded to include 
for the first time a health care tax credit, and eligible recipients 
now include secondarily affected workers impacted by foreign trade. 
Income support is extended by 26 weeks and by up to one year under 
certain conditions. Waivers of training requirements in order to 
receive income support are explicitly defined. Job search and 
relocation benefit amounts are increased. Within one year of enactment, 
the amendments offer an Alternative TAA for Older Workers program that 
targets older worker groups who are certified as TAA eligible and 
provides the option of a wage supplement instead of training, job 
search, and income support.


The Department is mandated to implement the amendments within 90 days 
from enactment (November 4, 2002), and it issued operating instructions 
in a guidance letter on October 10, 2002, and later published in the 
Federal Register (67 FR 69029-41). State agencies rely on the 
regulations to make determinations as to individual eligibility for TAA 
program benefits. TAA program regulations as written have been 
described as complicated to interpret. With the new TAA program benefit 
amendments contained in the Trade Act of 2002, it is imperative that 
the regulations be in an easy-to-read and understandable format.


Summary of Legal Basis:


These regulations are authorized by 19 U.S.C. 2320 due to the 
amendments to the Trade Act of 1974 by the Trade Adjustment Assistance 
Reform Act of 2002.


Alternatives:


The public will be afforded an opportunity to provide comments on the 
TAA program changes when the Department publishes the proposed rule in 
the Federal Register.


Anticipated Cost and Benefits:


Preliminary estimates of the anticipated costs of this regulatory 
action have not been determined at this time and will be determined at 
a later date.


Risks:


This action does not affect public health, safety, or the environment.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           04/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, State


Agency Contact:
Timothy F. Sullivan
Director, Trade Adjustment Assistance
Department of Labor
Employment and Training Administration
Room S4231
200 Constitution Avenue NW
FP Building, C5311
Washington, DC 20210
Phone: 202 693-3708
Email: [email protected]
RIN: 1205-AB32
_______________________________________________________________________



DOL--ETA



91.  REVISION TO THE DEPARTMENT OF LABOR REGULATIONS FOR 
PETITIONS AND DETERMINATIONS OF ELIGIBILITY TO APPLY FOR TRADE 
ADJUSTMENT ASSISTANCE FOR WORKERS AND ISSUANCE OF REGULATIONS FOR THE 
ALTERNATIVE TAA
Priority:


Other Significant. Major status under 5 USC 801 is undetermined.


Legal Authority:


19 USC 2320; Secretary's Order No. 3-81, 46 FR 31117


CFR Citation:


29 CFR 90; 20 CFR 617; 20 CFR 618; 20 CFR 665; 20 CFR 671; . . .


Legal Deadline:


None


Abstract:


The Trade Adjustment Assistance Reform Act of 2002, enacted on August 
6, 2002, contains provisions amending title 2, chapter 2 of the Trade 
Act of 1974, entitled Adjustment Assistance for Workers. The 
amendments, effective 90 days from enactment (November 4, 2002), make 
additions to where and by whom a petition may be filed, expand 
eligibility to workers whose production has been shifted to certain 
foreign countries and to worker groups secondarily affected, and make 
substantive changes regarding trade adjustment assistance (TAA) program 
benefits.


It is the agency's intention to create a new 20 CFR part 618 to 
incorporate the amendments and write it in plain English, while 
amending the WIA regulations at 20 CFR parts 665 and 671 regarding 
Rapid Response and National Emergency Grants as they relate to the TAA 
program.


The proposed part 618 consists of nine subparts: subpart A--General; 
subpart B--Petitions and Determinations of Eligibility to Apply for 
Trade Adjustment Assistance (and Alternative TAA); subpart C--Delivery 
of Services throughout the One-Stop Delivery System; subpart D--Job 
Search Allowances; subpart E--Relocation Allowances; subpart F--
Training Services; subpart G--Trade Readjustment Allowances (TRA); 
subpart H--Administration by Applicable State Agencies; and subpart I--
Alternative Trade Adjustment Assistance (ATAA) for Older Workers. 
Because of the complexity of the subject matter and the States' needs 
for definitive instructions on providing TAA benefits, the rulemaking 
for part 618 is divided into two parts. This notice of proposed 
rulemaking covers the petitions and determinations (subpart B) and ATAA 
(subpart I) of the regulations. A separate notice of proposed 
rulemaking will cover the remaining subparts (subpart A and subparts C 
through H).


Statement of Need:


The Trade Adjustment Assistance Reform Act of 2002, enacted August 6, 
2002, repeals the North American Free Trade Agreement-Transitional 
Adjustment Assistance provisions for workers affected by the NAFTA 
Implementation Act and adds significant amendments to worker benefits 
under Trade Adjustment Assistance for Workers, as provided for in the 
Trade Act of 1974.


The 2002 Trade Act amends where and by whom a petition may be filed. 
Program benefits for TAA eligible recipients are expanded to include 
for the first time a health care tax credit,

[[Page 72786]]

and eligible recipients now include secondarily affected workers 
impacted by foreign trade. Income support is extended by 26 weeks and 
by up to one year under certain conditions. Waivers of training 
requirements in order to receive income support are explicitly defined. 
Job search and relocation benefit amounts are increased. Within one 
year of enactment, the amendments offer an Alternative TAA for Older 
Workers program that targets older worker groups who are certified as 
TAA eligible and provides the option of a wage supplement instead of 
training, job search, and income support.


The Department is mandated to implement the amendments within 90 days 
from enactment (November 4, 2002), and it issued operating instructions 
in a guidance letter on October 10, 2002, and later published in the 
Federal Register (67 FR 69029-41). State agencies rely on the 
regulations to make determinations as to individual eligibility for TAA 
program benefits. TAA program regulations as written have been 
described as complicated to interpret. With the new TAA program benefit 
amendments contained in the Trade Act of 2002, it is imperative that 
the regulations be in an easy-to-read and understandable format.


Summary of Legal Basis:


These regulations are authorized by 19 U.S.C. 2320 due to the 
amendments to the Trade Act of 1974 by the Trade Adjustment Assistance 
Reform Act of 2002.


Alternatives:


The public will be afforded an opportunity to provide comments on the 
TAA program changes when the Department publishes the proposed rule in 
the Federal Register.


Anticipated Cost and Benefits:


Preliminary estimates of the anticipated costs of this regulatory 
action have not been determined at this time and will be determined at 
a later date.


Risks:


This action does not affect public health, safety, or the environment.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           04/00/05
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


Federal, State


Agency Contact:
Timothy F. Sullivan
Director, Trade Adjustment Assistance
Department of Labor
Employment and Training Administration
Room S4231
200 Constitution Avenue NW
FP Building, C5311
Washington, DC 20210
Phone: 202 693-3708
Email: [email protected]
RIN: 1205-AB40
_______________________________________________________________________



DOL--ETA

                              -----------

                            FINAL RULE STAGE

                              -----------




92. LABOR CERTIFICATION PROCESS FOR THE PERMANENT EMPLOYMENT OF ALIENS 
IN THE UNITED STATES
Priority:


Other Significant


Legal Authority:


29 USC 49 et seq; 8 USC 1182(a)(5)(A), 1189(p)(1)


CFR Citation:


20 CFR 656


Legal Deadline:


None


Abstract:


The Employment and Training Administration (ETA) is in the process of 
reengineering the permanent labor certification process. ETA's goals 
are to make fundamental changes and refinements that will streamline 
the process, save resources, improve the effectiveness of the program 
and better serve the Department of Labor's (DOL) customer.


Statement of Need:


The labor certification process has been described as being 
complicated, costly and time consuming. Due to the increases in the 
volume of applications received and a lack of adequate resources, it 
can take up to 2 years or more to complete processing an application. 
The process also requires substantial State and Federal resources to 
administer and is reportedly costly and burdensome to employers as 
well. Cuts in Federal funding for both the permanent labor 
certification program and the U.S. Employment Service have made it 
difficult for State and Federal administrators to keep up with the 
process. ETA, therefore, is taking steps to improve effectiveness of 
the various regulatory requirements and the application processing 
procedures, with a view to achieving savings in resources both for the 
Government and employers, without diminishing protections now afforded 
U.S. workers by the current regulatory and administrative requirements.


Summary of Legal Basis:


Promulgation of these regulations is authorized by section 212(a)(5)(A) 
of the Immigration and Nationality Act.


Alternatives:


Regulatory alternatives are now being developed by the Department. The 
public was afforded an opportunity to comment on the Department's plans 
for streamlining the permanent labor certification process in a notice 
of proposed rulemaking which was published in the Federal Register on 
May 6, 2002.


Anticipated Cost and Benefits:


Preliminary estimates of the anticipated costs and benefits have not 
been determined at this time. Preliminary estimates will be developed 
after a decision is made as to what regulatory amendments are necessary 
and after the implementing forms and automated systems to support a 
streamlined permanent labor certification process have been developed.


Risks:


This action does not affect public health, safety, or the environment.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            67 FR 30465                                    05/06/02
NPRM Comment Period End                                        07/05/02
Final Action                                                   12/00/04
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


Federal, State

[[Page 72787]]

Agency Contact:
William L. Carlson
Chief, Division of Foreign Labor Certification
Department of Labor
Employment and Training Administration
200 Constitution Avenue NW.
Room C4312 FP Building
Washington, DC 20210
Phone: 202 693-3010
Fax: 202 693-2768
Email: [email protected]
RIN: 1205-AA66
_______________________________________________________________________



DOL--Employee Benefits Security Administration (EBSA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




93. RULEMAKING RELATING TO TERMINATION OF ABANDONED INDIVIDUAL ACCOUNT 
PLANS
Priority:


Other Significant. Major status under 5 USC 801 is undetermined.


Legal Authority:


29 USC 1135; 29 USC 1002(16)(A)


CFR Citation:


29 CFR 2591


Legal Deadline:


None


Abstract:


This rulemaking will establish a procedure and standards for 
distributing the benefits of individual account plans that have been 
abandoned by their sponsoring employers or plan administrators.


Statement of Need:


Thousands of individual account plans have, for a variety of reasons, 
been abandoned by their sponsors, creating problems for plan 
participants, administrators, financial institutions (e.g., banks, 
insurance companies, mutual funds), the courts and the Federal 
Government. At present, the potential liability and costs attendant to 
terminating such plans and distributing the assets inhibits financial 
institutions and others from taking on this responsibility. Due to 
ongoing administrative costs and other factors, the continued 
maintenance of such plans is often not in the interest of the 
participants and beneficiaries. This rulemaking will establish a 
procedure for a financial institution that holds the assets of such a 
plan to terminate the plan and distribute its assets to the 
participants and beneficiaries. The rulemaking will also include 
standards for determining when plans may be terminated pursuant to this 
procedure and for carrying out the functions necessary to distribute 
benefits and shut down plan operations.


Summary of Legal Basis:


Section 505 of ERISA provides that the Secretary may prescribe such 
regulations as the Secretary finds necessary and appropriate to carry 
out the provisions of title I of the Act. Section 403(d)(1) provides 
that, upon termination of such a plan, the assets shall be distributed 
generally in accordance with the provisions that apply to defined 
benefit plans, ``except as otherwise provided in regulations of the 
Secretary.'' ERISA section 3(16)(A) permits the Secretary to issue 
regulations designating an administrator for a plan where the plan 
document makes no designation and the plan sponsor cannot be 
identified.


Alternatives:


Alternatives will be considered following a determination of the scope 
and nature of the regulatory guidance needed by the public.


Anticipated Cost and Benefits:


Preliminary estimates of the anticipated costs and benefits will be 
developed, as appropriate, following a determination regarding the 
alternatives to be considered.


Risks:


Failure to provide guidance in this area will leave the retirement 
benefits of participants and beneficiaries in abandoned plans at risk 
of being significantly diminished by ongoing plan administrative 
expenses, rather than distributed to participants and beneficiaries in 
connection with a timely and orderly termination of the plan.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           01/00/05
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


 Businesses, Organizations


Government Levels Affected:


None


Agency Contact:
Jeffrey Turner
Senior Pension Law Specialist
Department of Labor
Employee Benefits Security Administration
N 5669
200 Constitution Avenue NW
Room N5669
FP Building
Washington, DC 20210
Phone: 202 693-8500
RIN: 1210-AA97
_______________________________________________________________________



DOL--EBSA



94.  AMENDMENT OF REGULATION RELATING TO DEFINITION OF PLAN 
ASSETS--PARTICIPANT CONTRIBUTIONS
Priority:


Other Significant. Major status under 5 USC 801 is undetermined.


Unfunded Mandates:


Undetermined


Legal Authority:


29 USC 1135


CFR Citation:


29 CFR 2510.3-102


Legal Deadline:


None


Abstract:


This rulemaking will amend the regulation that defines when participant 
monies paid to or withheld by an employer for contribution to an 
employee benefit plan constitute ``plan assets'' for purposes of title 
I of ERISA and the related prohibited transaction provisions of the 
Internal Revenue Code. The regulation contains an amendment to the 
current regulation that will establish a safe harbor period of a 
specified number of business days during which certain monies that a 
participant pays to, or has withheld by, an employer for contribution 
to a plan would not constitute ``plan assets.''


Statement of Need:


This amendment of the participant contribution regulation would, upon 
adoption, establish a ``safe harbor'' period of a specified number of 
days during which certain monies that a participant pays to, or has 
withheld from wages, by an employer for contribution to an employee 
benefit plan, would constitute plan assets for purposes of title I of 
ERISA and the related prohibited transaction

[[Page 72788]]

provisions of the Internal Revenue Code. The amendment is needed to 
provide greater certainty to employers, participants and beneficiaries, 
service providers and others concerning when participant contributions 
to a plan constitute plan assets.


Summary of Legal Basis:


Section 505 of ERISA provides that the Secretary may prescribe such 
regulations as she finds necessary and appropriate to carry out the 
provisions of title I of the Act. Regulation 29 CFR 2510.3-102 provides 
that the assets of an employee benefit plan covered by title I of ERISA 
includes amounts (other than union dues) that a participant or 
beneficiary pays to an employer, or has withheld from wages by an 
employer, for contribution to the plan as of the earliest date on which 
such contributions can reasonably be segregated from the employer's 
general assets; the regulation also specifies the maximum time period 
for deposit of such contributions by the employer.


Alternatives:


Alternatives will be considered following a determination of the scope 
and nature of the regulatory guidance needed by the public.


Anticipated Cost and Benefits:


Preliminary estimates of the anticipated costs and benefits will be 
developed, as appropriate, following a determination regarding the 
alternatives to be considered.


Risks:


Failure to provide the safe harbor that would be afforded by the 
proposed amendment with regard to monies contributed to employee 
benefit plans would deprive employers, other plan fiduciaries, and 
service providers of the certainty they need to optimize compliance 
with the law. Also, any risk of loss or lost earnings resulting from 
permitting employers who would otherwise transmit contributions to the 
plan sooner than the time specified in the safe harbor should be 
minimal, while the benefits attendant to encouraging employers to 
review and modify their systems or practices to take advantage of the 
safe harbor may be significant.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/04
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


None


Federalism:


 Undetermined


Agency Contact:
Louis J. Campagna
Chief, Division of Fiduciary Interpretations, Office of Regulations and 
Interpretations
Department of Labor
Employee Benefits Security Administration
200 Constitution Avenue NW
Rm N5669
FP Building
Washington, DC 20210
Phone: 202 693-8512
Fax: 202 219-7291
RIN: 1210-AB02
_______________________________________________________________________



DOL--EBSA

                              -----------

                            FINAL RULE STAGE

                              -----------




95. REGULATIONS IMPLEMENTING THE HEALTH CARE ACCESS, PORTABILITY, AND 
RENEWABILITY PROVISIONS OF THE HEALTH INSURANCE PORTABILITY AND 
ACCOUNTABILITY ACT OF 1996
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


29 USC 1027; 29 USC 1059; 29 USC 1135; 29 USC 1171; 29 USC 1172; 29 USC 
1191c


CFR Citation:


29 CFR 2590


Legal Deadline:


Other, Statutory, April 1, 1997, Interim Final Rule.


Abstract:


The Health Insurance Portability and Accountability Act of 1996 (HIPAA) 
amended title I of ERISA by adding a new part 7, designed to improve 
health care access, portability and renewability. This rulemaking will 
provide regulatory guidance to implement these provisions.


Statement of Need:


In general, the health care portability provisions in part 7 of ERISA 
provide for increased portability and availability of group health 
coverage through limitations on the imposition of any preexisting 
condition exclusion and special enrollment rights in group health plans 
after loss of other health coverage or a life event. Plan sponsors, 
administrators and participants need guidance from the Department with 
regard to how they can fulfill their respective obligations under these 
statutory provisions.


Summary of Legal Basis:


Part 7 of ERISA specifies the portability and other requirements for 
group health plans and health insurance issuers. Section 734 of ERISA 
provides that the Secretary may promulgate such regulations as may be 
necessary or appropriate to carry out the provisions of part 7 of 
ERISA. In addition, section 505 of ERISA authorizes the Secretary to 
issue regulations clarifying the provisions of title I of ERISA.


Risks:


Failure to provide guidance concerning part 7 of ERISA may impede 
compliance with the law.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Interim Final Ru62 FR 16894                                    04/08/97
Interim Final Rule Effective                                   06/07/97
Interim Final Rule Comment Period End                          07/07/97
Request for Info64 FR 57520                                    10/25/99
Comment Period End                                             01/25/00
Final Rule                                                     12/00/04
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None


Federalism:


 This action may have federalism implications as defined in EO 13132.


Agency Contact:
Amy Turner
Pension Law Specialist
Department of Labor
Employee Benefits Security Administration
Room N5677
200 Constitution Avenue NW
FP Building
Washington, DC 20210
Phone: 202 693-8335
RIN: 1210-AA54

[[Page 72789]]

_______________________________________________________________________



DOL--EBSA



96. PROHIBITING DISCRIMINATION AGAINST PARTICIPANTS AND BENEFICIARIES 
BASED ON HEALTH STATUS
Priority:


Other Significant. Major status under 5 USC 801 is undetermined.


Legal Authority:


29 USC 1027; 29 USC 1059; 29 USC 1135; 29 USC 1182; 29 USC 1191c; 29 
USC 1194


CFR Citation:


29 CFR 2590.702


Legal Deadline:


None


Abstract:


Section 702 of the Employee Retirement Income Security Act of 1974, 
amended by the Health Insurance Portability and Accountability Act of 
1996 (HIPAA), establishes that a group health plan or a health 
insurance issuer may not establish rules for eligibility (including 
continued eligibility) of any individual to enroll under the terms of 
the plan based on any health status-related factor. These provisions 
are also contained in the Internal Revenue Code under the jurisdiction 
of the Department of the Treasury, and the Public Health Service Act 
under the jurisdiction of the Department of Health and Human Services.


On April 8, 1997, the Department, in conjunction with the Departments 
of the Treasury and Health and Human Services (collectively, the 
Departments) published interim final regulations implementing the 
nondiscrimination provisions of HIPAA. These regulations can be found 
at 26 CFR 54.9802-1 (Treasury), 29 CFR 2590.702 (Labor), and 45 CFR 
146.121 (HHS). That notice of rulemaking also solicited comments on the 
nondiscrimination provisions and indicated that the Departments intend 
to issue further regulations on the nondiscrimination rules. This 
rulemaking contains additional regulatory interim guidance under 
HIPAA's nondiscrimination provisions. In addition, the rulemaking 
contains proposed guidance on bona fide wellness programs.


Statement of Need:


Part 7 of ERISA provides that group health plans and health insurance 
issuers may not establish rules for eligibility (including continued 
eligibility) of any individual to enroll under the terms of the plan 
based on any health status-related factor. Plan sponsors, 
administrators, and participants need additional guidance from the 
Department with regard to how they can fulfill their respective 
obligations under these statutory provisions.


Summary of Legal Basis:


Section 702 of ERISA specifies the respective nondiscrimination 
requirements for group health plans and health insurance issuers. 
Section 734 of ERISA provides that the Secretary may promulgate such 
regulations as may be necessary or appropriate to carry out the 
provisions of part 7 ERISA. In addition, section 505 of ERISA 
authorizes the Secretary to issue regulations clarifying the provisions 
of title I of ERISA.


Risks:


Failure to provide guidance concerning part 7 of ERISA may impede 
compliance with the law.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Interim Final Ru62 FR 16894                                    04/08/97
Interim Final Rule Comment Period End                          07/07/97
NPRM            66 FR 1421                                     01/08/01
NPRM Comment Period End                                        04/09/01
Second Interim F66 FR 1378                                     01/08/01
Interim Final Rule Comment Period End                          04/09/01
Final Rule                                                     03/00/05
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


Undetermined


Additional Information:


This item has been split off from RIN 1210-AA54.


Agency Contact:
Amy Turner
Pension Law Specialist
Department of Labor
Employee Benefits Security Administration
Room N5677
200 Constitution Avenue NW
FP Building
Washington, DC 20210
Phone: 202 693-8335
RIN: 1210-AA77
_______________________________________________________________________



DOL--Mine Safety and Health Administration (MSHA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




97. ASBESTOS EXPOSURE LIMIT
Priority:


Other Significant


Legal Authority:


30 USC 811; 30 USC 813


CFR Citation:


30 CFR 56; 30 CFR 57; 30 CFR 71


Legal Deadline:


None


Abstract:


MSHA's permissible exposure limit (PEL) for asbestos applies to surface 
(30 CFR part 56) and underground (30 CFR part 57) metal and nonmetal 
mines and to surface coal mines and surface areas of underground coal 
mines (30 CFR part 71) and is over 20 years old. MSHA is considering 
rulemaking to lower the PEL in order to reduce the risk of miners 
developing asbestos-induced occupational disease. A report by the 
Office of the Inspector General (OIG) recommended that MSHA lower its 
existing permissible exposure limit for asbestos to a more protective 
level, and address take-home contamination from asbestos. It also 
recommended that MSHA use Transmission Electron Microscopy to analyze 
fiber samples that may contain asbestos.


Statement of Need:


Current scientific data indicate that the existing asbestos PEL is not 
sufficiently protective of miners' health. MSHA's asbestos regulations 
date to 1967 and are based on the Bureau of Mines (MSHA's predecessor) 
standard of 5 mppcf (million particles per cubic foot of air). In 1969, 
the Bureau proposed a 2 mppcf and 12 fibers/ml standard. This standard 
was promulgated in 1969. In 1970, the Bureau proposed to lower the 
standard to 5 fibers/ml, which was promulgated in 1974. MSHA issued its 
current standard of 2 fibers/ml in 1976 for coal mining (41 FR 10223) 
and 1978 for metal and nonmetal mining (43 FR 54064). During 
inspections, MSHA routinely takes samples, which are analyzed for 
compliance with its standard.


Other Federal agencies have addressed this issue by lowering their PEL 
for asbestos. For example, the Occupational Safety and Health

[[Page 72790]]

Administration, working in conjunction with the Environmental 
Protection Agency, enacted a revised asbestos standard in 1994 that 
lowered the permissible exposure limit to an 8-hour time-weighted 
average limit of 0.1 fiber per cubic centimeter of air and the 
excursion limit to 1.0 fiber per cubic centimeter of air (1 f/cc) as 
averaged over a sampling period of thirty (30) minutes. These lowered 
limits reflected increased asbestos-related disease risk to asbestos-
exposed workers.


Summary of Legal Basis:


Promulgation of this regulation is authorized by section 101 of the 
Federal Mine Safety and Health Act of 1977.


Alternatives:


The Agency has increased sampling efforts in an attempt to determine 
current miners' exposure levels to asbestos, including taking samples 
at all existing vermiculite, taconite, talc, and other mines to 
determine whether asbestos is present and at what levels. In early 
2000, MSHA began an intensive sampling effort at operations with 
potential asbestos exposure. These efforts continue. While sampling, 
MSHA staff discussed with miners and mine operators the potential 
hazards of asbestos and the types of preventive measures that could be 
implemented to reduce exposures. The course of action MSHA takes in 
addressing asbestos hazards to miners will, in part, be based on these 
sampling results.


Anticipated Cost and Benefits:


MSHA will develop a preliminary regulatory economic analysis to 
accompany any proposed rule that may be developed.


Risks:


Miners could be exposed to the hazards of asbestos during mine 
operations where the ore body contains asbestos. There is also 
potential for exposure at facilities in which installed asbestos-
containing material is present. Overexposure to asbestos causes 
asbestosis, mesothelioma, and other forms of cancers.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           67 FR 15134                                    03/29/02
Notice of Public Meetings                                      03/29/02
Notice of Change67 FR 19140Meetings                            04/18/02
ANPRM Comment Period End                                       06/27/02
NPRM                                                           03/00/05
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


 Businesses


Government Levels Affected:


None


Additional Information:


The Office of the Inspector General's ``Evaluation of MSHA's Handling 
of Inspections at the W.R. Grace & Company Mine in Libby, Montana,'' 
was issued in March 2001.


Agency Contact:
Marvin W. Nichols Jr.
Director, Office of Standards
Department of Labor
Mine Safety and Health Administration
Room 2352
1100 Wilson Boulevard
Room 2350
Arlington, VA 22209
Phone: 202 693-9440
Fax: 202 693-9441
Email: [email protected]
RIN: 1219-AB24
_______________________________________________________________________



DOL--MSHA

                              -----------

                            FINAL RULE STAGE

                              -----------




98. DIESEL PARTICULATE MATTER EXPOSURE OF UNDERGROUND METAL AND 
NONMETAL MINERS
Priority:


Other Significant


Legal Authority:


30 USC 811; 30 USC 813


CFR Citation:


30 CFR 57


Legal Deadline:


None


Abstract:


On January 19, 2001, MSHA published a final rule addressing diesel 
particulate matter (DPM) exposure of underground metal and nonmetal 
miners (66 FR 5706). The final rule established new health standards 
for underground metal and nonmetal mines that use equipment powered by 
diesel engines. The rule establishes an interim concentration limit of 
400 micrograms of total carbon per cubic meter of air that became 
applicable July 20, 2002, and a final concentration limit of 160 
micrograms to become applicable after January 19, 2006. Industry 
challenged the rule and organized labor intervened in the litigation. 
Settlement negotiations with the litigants have resulted in further 
regulatory actions on several requirements of the rule. One final rule 
has been published (67 FR 9180). This new rulemaking will address many 
of the remaining issues. MSHA issued an advance notice of proposed 
rulemaking (ANPRM) on September 25, 2002 (67 FR 60199) to obtain 
additional information and published a notice of proposed rulemaking 
(NPRM) in August 2003.


Statement of Need:


As a result of the first partial settlement with the litigants, MSHA 
published two documents in the Federal Register on July 5, 2001. One 
document delayed the effective date of 57.5066(b) regarding the tagging 
provisions of the maintenance standard; clarified the effective dates 
of certain provisions of the final rule; and gave correction amendments 
(66 FR 35518).


The second document was a proposed rule to clarify 57.5066(b)(1) and 
(b)(2) of the maintenance standards and to add a new paragraph (b)(3) 
to 57.5067 regarding the transfer of existing diesel equipment from one 
underground mine to another underground mine. The final rule on these 
issues was published February 27, 2002, and became effective March 29, 
2002.


As a result of the second partial settlement agreement, MSHA proposed 
specific changes to the 2001 DPM final rule. On September 25, 2002, 
MSHA published an ANPRM. In response to commenters, MSHA proposed 
changes only to the interim DPM standard of 400 micrograms per cubic 
meter of air. In a separate rulemaking, the Agency will propose a rule 
to revise the final concentration limit of 160 micrograms per cubic 
meter of air. The scope of both rulemakings is limited to the 
settlement agreement. The current rulemaking addresses the following 
provisions:


57.5060(a) - Whether to change the existing DPM surrogate for the 
interim limit from total carbon to elemental carbon; and change the 
concentration limit to a comparable permissible exposure limit.


57.5060(c) - Whether to adapt to the interim limit the existing 
provision that allows mine operators to apply to the Secretary for 
additional time to come into compliance with the final concentration 
limit. MSHA also agreed

[[Page 72791]]

to propose to include consideration of economic feasibility, and to 
allow for annual renewals of such special extensions.


57.5060(d) -- Whether to remove the existing provision permitting 
miners to engage in certain activities in concentrations exceeding the 
interim and final limits upon application and approval from the 
Secretary, since the Agency agreed to propose the current hierarchy of 
controls that MSHA applies in its existing metal and nonmetal exposure 
based health standards for abating violations.


57.5060(e) -- Whether to remove the existing prohibition on the use of 
personal protective equipment.


57.5060(f) - Whether to remove the prohibition on the use of 
administrative controls.


57.5061(a) -- Whether to change the reference from ``concentration'' to 
PEL.


57.5061(b) -- Whether to change the reference from ``total carbon'' to 
``elemental carbon.''


57.5061(c) - Whether to delete the references to ``area'' and 
``occupational'' sampling for compliance.


57.5062 -- Whether to revise the existing diesel control plan.


Summary of Legal Basis:


Promulgation of these regulations is authorized by sections 101 and 103 
of the Federal Mine Safety and Health Act of 1977.


Alternatives:


This rulemaking would amend and improve health protection from that 
afforded by the existing standard.


Anticipated Cost and Benefits:


MSHA's preliminary economic analysis indicates that making the changes 
under consideration would result in a cost savings to the mining 
industry.


Risks:


Several epidemiological studies have found that exposure to diesel 
exhaust presents potential health risks to miners. These potential 
adverse health effects range from headaches and nausea to respiratory 
disease and cancer. In the confined space of the underground mining 
environment, occupational exposure to diesel exhaust may present a 
greater hazard due to ventilation limitations and the presence of other 
airborne contaminants, such as toxic mine dusts or mine gases. We 
believe that the health evidence forms a reasonable basis for reducing 
miners' exposure to diesel particulate matter. Proceeding with 
rulemaking on the provisions discussed above will more effectively 
reduce miners' exposure to DPM.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           67 FR 60199                                    09/25/02
ANPRM Comment Period End                                       11/25/02
NPRM            68 FR 48668                                    08/14/03
NPRM Comment Period End                                        10/14/03
Limited Reopenin69 FR 7881omment Period                        02/20/04
Limited Reopenin69 FR 7881omment Period End                    04/05/04
Final Action                                                   03/00/05
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Marvin W. Nichols Jr.
Director, Office of Standards
Department of Labor
Mine Safety and Health Administration
1100 Wilson Boulevard, Room 2350
Arlington, VA 22209
Phone: 202 693-9440
Fax: 202 693-9441
Email: [email protected]
RIN: 1219-AB29
_______________________________________________________________________



DOL--Occupational Safety and Health Administration (OSHA)

                              -----------

                             PRERULE STAGE

                              -----------




99. OCCUPATIONAL EXPOSURE TO CRYSTALLINE SILICA
Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


Undetermined


Legal Authority:


29 USC 655(b); 29 USC 657


CFR Citation:


29 CFR 1910; 29 CFR 1915; 29 CFR 1917; 29 CFR 1918; 29 CFR 1926


Legal Deadline:


None


Abstract:


Crystalline silica is a significant component of the earth's crust, and 
many workers in a wide range of industries are exposed to it, usually 
in the form of respirable quartz or, less frequently, cristobalite. 
Chronic silicosis is a uniquely occupational disease resulting from 
exposure of employees over long periods of time (10 years or more). 
Exposure to high levels of respirable crystalline silica causes acute 
or accelerated forms of silicosis that are ultimately fatal. The 
current OSHA permissible exposure limit (PEL) for general industry is 
based on a formula recommended by the American Conference of 
Governmental Industrial Hygienists (ACGIH) in 1971 (PEL=10mg/cubic 
meter/(% silica + 2), as respirable dust). The current PEL for 
construction and maritime (derived from ACGIH's 1962 Threshold Limit 
Value) is based on particle counting technology, which is considered 
obsolete. NIOSH and ACGIH recommend a 50ug/m3 exposure limit for 
respirable crystalline silica.


Both industry and worker groups have recognized that a comprehensive 
standard for crystalline silica is needed to provide for exposure 
monitoring, medical surveillance, and worker training. The American 
Society for Testing and Materials (ASTM) has published a recommended 
standard for addressing the hazards of crystalline silica. The Building 
Construction Trades Department of the AFL-CIO has also developed a 
recommended comprehensive program standard. These standards include 
provisions for methods of compliance, exposure monitoring, training, 
and medical surveillance.


Statement of Need:


Over two million workers are exposed to crystalline silica dust in 
general industry, construction and maritime industries. Industries that 
could be particularly affected by a standard for crystalline silica 
include: foundries, industries that have abrasive blasting operations, 
paint manufacture, glass and concrete product manufacture, brick 
making, china and pottery manufacture, manufacture of plumbing 
fixtures, and many construction activities including highway repair, 
masonry, concrete work, rock drilling, and tuckpointing. The 
seriousness of the health hazards associated with silica exposure is 
demonstrated by the

[[Page 72792]]

fatalities and disabling illnesses that continue to occur; between 1990 
and 1996, 200 to 300 deaths per year are known to have occurred where 
silicosis was identified on death certificates as an underlying or 
contributing cause of death. It is likely that many more cases have 
occurred where silicosis went undetected. In addition, the 
International Agency for Research on Cancer (IARC) has designated 
crystalline silica as a known human carcinogen. Exposure to crystalline 
silica has also been associated with an increased risk of developing 
tuberculosis and other nonmalignant respiratory diseases, as well as, 
renal and autoimmune respiratory diseases. Exposure studies and OSHA 
enforcement data indicate that some workers continue to be exposed to 
levels of crystalline silica far in excess of current exposure limits. 
Congress has included compensation of silicosis victims on Federal 
nuclear testing sites in the Energy Employees' Occupational Illness 
Compensation Program Act of 2000. There is a particular need for the 
Agency to modernize its exposure limits for construction and maritime, 
and to address some specific issues that will need to be resolved to 
propose a comprehensive standard.


Summary of Legal Basis:


The legal basis for the proposed rule is a preliminary determination 
that workers are exposed to a significant risk of silicosis and other 
serious disease and that rulemaking is needed to substantially reduce 
the risk. In addition, the proposed rule will recognize that the PELs 
for construction and maritime are outdated and need to be revised to 
reflect current sampling and analytical technologies.


Alternatives:


Over the past several years, the Agency has attempted to address this 
problem through a variety of non-regulatory approaches, including 
initiation of a Special Emphasis Program on silica in October 1997, 
sponsorship with NIOSH and MSHA of the National Conference to Eliminate 
Silicosis, and dissemination of guidance information on its Web site. 
OSHA has determined that rulemaking is a necessary step to ensure that 
workers are protected from the hazards of crystalline silica. The 
Agency is currently evaluating several options for the scope of the 
rulemaking.


Anticipated Cost and Benefits:


The scope of the proposed rulemaking and estimates of the costs and 
benefits are still under development.


Risks:


A detailed risk analysis is under way.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Completed SBREFA Report                                        12/19/03
Complete Peer Review of Risk Assessment                        02/00/05
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Undetermined


Agency Contact:
Steven F. Witt
Director, Directorate of Standards and Guidance
Department of Labor
Occupational Safety and Health Administration
200 Constitution Avenue NW.
Room N-3718, FP Building
Washington, DC 20210
Phone: 202 693-1950
Fax: 202 693-1678
RIN: 1218-AB70
_______________________________________________________________________



DOL--OSHA

                              -----------

                          PROPOSED RULE STAGE

                              -----------




100. OCCUPATIONAL EXPOSURE TO HEXAVALENT CHROMIUM (PREVENTING 
OCCUPATIONAL ILLNESS: CHROMIUM)
Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


This action may affect the private sector under PL 104-4.


Legal Authority:


29 USC 655(b); 29 USC 657


CFR Citation:


29 CFR 1910


Legal Deadline:


NPRM, Judicial, October 4, 2004.


Abstract:


In July 1993, the Occupational Safety and Health Administration (OSHA) 
was petitioned for an emergency temporary standard (ETS) to reduce the 
permissible exposure limit (PEL) for occupational exposures to 
hexavalent chromium (CrVI). The Oil, Chemical, and Atomic Workers 
International Unions (OCAW) and Public Citizen's Health Research Group 
(HRG) petitioned OSHA to promulgate an ETS to lower the PEL for CrVI 
compounds to 0.5 micrograms per cubic meter of air (ug/m3) as an eight-
hour, time-weighted average (TWA). The current PEL in general industry 
is a ceiling value of 100 ug/m3, measured as CrVI and reported as 
chromic anhydride (CrO3). The amount of CrVI in the anhydride compound 
equates to a PEL of 52 ug/m3. The ceiling limit applies to all forms of 
CrVI, including chromic acid and chromates, lead chromate, and zinc 
chromate. The current PEL of CrVI in the construction industry is 100 
ug/m3 as a TWA PEL, which also equates to a PEL of 52 ug/m3. After 
reviewing the petition, OSHA denied the request for an ETS and 
initiated a section 6(b)(5) rulemaking.


OSHA began collecting data and performing preliminary analyses relevant 
to occupational exposure to CrVI. However, in 1997, OSHA was sued by 
HRG OCAW for unreasonable delay in issuing a final CrVI standard. The 
3rd Circuit, U.S. Court of Appeals ruled in OSHA's favor and the Agency 
continued its data collection and analytic efforts on CrVI. In 2002, 
OSHA was sued again by HRG and Paper, Allied-International, Chemical 
and Energy Workers Ineternational Union (PACE) for continued 
unreasonable delay in issuing a final CrVI standard. In August, 2002 
OSHA published a Request for Information on CrVI to solicit additional 
information on key issues related to controlling exposures to CrVI and 
on December 4, 2002, OSHA announced its intent to proceed with 
developing a proposed standard. On December 24, 2002, the 3rd Circuit, 
U.S. Court of Appeals ruled in favor of HRG and ordered the Agency to 
proceed expeditiously with a CrVI standard.


Statement of Need:


Approximately 380,000 workers are exposed to CrVI in general industry, 
maritime, construction, and agriculture. Industries or work processes 
that could be particularly affected by a standard for CrVI include: 
Electroplating, welding, painting, chromate production, chromate 
pigment production, ferrochromium production, iron and steel 
production, chromium catalyst production, and chromium dioxide and 
sulfate production.

[[Page 72793]]

Exposure to CrVI has been shown to produce lung cancer, an often fatal 
disease, among workers exposed to CrVI compounds. The International 
Agency for Research on Cancer (IARC) classifies CrVI compounds as a 
Group 1 Carcinogen: Agents considered to be carcinogenic in humans. The 
Environmental Protection Agency (EPA) and the American Conference of 
Governmental Industrial Hygienists (ACGIH) have also designated CrVI 
compounds as known and confirmed human carcinogens, respectively. 
Similarly, the National Institute for Occupational Safety and Health 
(NIOSH) considers CrVI compounds to be potential occupational 
carcinogens. OSHA's current standards for CrVI compounds, adopted in 
1971, were established to protect against nasal irritation. Therefore, 
there is a need to revise the current standard to protect workers from 
lung cancer.


Summary of Legal Basis:


The legal basis for the proposed rule is a preliminary determination 
that workers are exposed to a significant risk of lung cancer and 
dermatoses and that rulemaking is needed to substantially reduce the 
risk.


Alternatives:


OSHA had considered non-regulatory approaches, including the 
dissemination of guidance on its web site. However, OSHA has determined 
that rulemaking is a necessary step to ensure that workers are 
protected from the hazards of CrVI and the Agency has been ordered by 
the U.S. Court of Appeals to move forward with a final rule.


Anticipated Cost and Benefits:


The proposed rulemaking includes estimates of the costs and benefits 
are being developed.


Risks:


A detailed risk analysis is included in the NPRM.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Request for Info67 FR 54389                                    08/22/02
Comment Period End                                             11/20/02
Initiate SBREFA Process                                        12/23/03
SBREFA Report                                                  04/20/04
NPRM            69 FR 59305                                    10/04/04
NPRM Comment Period End                                        01/03/05
Public Hearings                                                02/00/05
Final Rule                                                     01/00/06
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses, Governmental Jurisdictions


Government Levels Affected:


Undetermined


Agency Contact:
Steven F. Witt
Director, Directorate of Standards and Guidance
Department of Labor
Occupational Safety and Health Administration
200 Constitution Avenue NW.
Room N-3718, FP Building
Washington, DC 20210
Phone: 202 693-1950
Fax: 202 693-1678
RIN: 1218-AB45
_______________________________________________________________________



DOL--OSHA

                              -----------

                            FINAL RULE STAGE

                              -----------




101. ASSIGNED PROTECTION FACTORS: AMENDMENTS TO THE FINAL RULE ON 
RESPIRATORY PROTECTION
Priority:


Other Significant


Legal Authority:


29 USC 655(b); 29 USC 657


CFR Citation:


29 CFR 1910.134


Legal Deadline:


None


Abstract:


In January 1998, OSHA published the final Respiratory Protection 
standard (29 CFR 1910.134), except for reserved provisions on assigned 
protection factors (APFs) and maximum use concentrations (MUCs). APFs 
are numbers that describe the effectiveness of the various classes of 
respirators in reducing employee exposure to airborne contaminants 
(including particulates, gases, vapors, biological agents, etc.). 
Employers, employees, and safety and health professionals use APFs to 
determine the type of respirator to protect the health of employees in 
various hazardous environments. Maximum use concentrations establish 
the maximum airborne concentration of a contaminant in which a 
respirator with a given APF may be used.


Currently, OSHA relies on the APFs developed by NIOSH in the 1980s 
unless OSHA has assigned a different APF in a substance-specific health 
standard. However, many employers follow the more recent APFs published 
in the industry consensus standard, ANSI Z88.2-1992. For some classes 
of respirators, the NIOSH and ANSI APFs vary greatly.


This rulemaking action will complete the 1998 standard, reduce 
compliance confusion among employers, and provide employees with 
consistent and appropriate respiratory protection. On June 6, 2003, 
OSHA published an NPRM on Assigned Protection Factors in the Federal 
Register at 68 FR 34036 containing a proposed APF table, and requesting 
public comment. The extended comment period ended October 2, 2003, and 
an informal public hearing was held January 28-30, 2004.


Statement of Need:


About five million employees wear respirators as part of their regular 
job duties. Due to inconsistencies between the APFs found in the 
current industry consensus standard (ANSI Z88.2-1992) and in the NIOSH 
Respirator Decision Logic, employers, employees, and safety and health 
professionals are often uncertain about what respirator to select to 
provide protection against hazardous air contaminants.


Summary of Legal Basis:


The legal basis for this proposed rule is the determination that 
assigned protection factors and maximum use concentrations are 
necessary to complete the final Respiratory Protection standard and 
provide the full protection under that standard.


Alternatives:


OSHA has considered allowing the current situation to continue. 
Accordingly, OSHA generally enforces NIOSH APFs, but many employers 
follow the more recent consensus standard APFs. However, allowing the 
situation to continue results in inconsistent enforcement, lack of 
guidance for employers, and the potential for inadequate employee 
protection.


Anticipated Cost and Benefits:


The estimated compliance costs for OSHA's proposed APF rule are $4.6 
million. The APFs proposed in this rulemaking help to ensure that the 
benefits attributed to proper respiratory

[[Page 72794]]

protection under 29 CFR 1910.134 are achieved, as well as provide an 
additional degree of protection.


Risks:


The preamble to the final Respiratory Protection rule (63 FR 1270, Jan. 
8, 1998) discusses the significance of the risks potentially associated 
with the use of respiratory protection. No independent finding of 
significant risk has been made for the APF rulemaking since it only 
addresses a single provision of the larger rule.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           47 FR 20803                                    05/14/82
ANPRM Comment Period End                                       09/13/82
NPRM            59 FR 58884                                    11/15/94
Final Rule      63 FR 1152                                     01/08/98
Final Rule Effective                                           04/08/98
NPRM            68 FR 34036                                    06/06/03
NPRM Comment Period End                                        09/04/03
NPRM Comment Per68 FR 53311d                                   10/02/03
Public Hearing o68 FR 640364                                   11/12/03
Final Rule: Revo68 FR 75767espiratory Protection M. TB         12/31/03
Public Hearing                                                 01/28/04
Post-Hearing Com69 FR 16510ief Period Extended                 03/30/04
Post-Hearing Comment Period End                                04/29/04
Post-Hearing Briefs End                                        05/29/04
Final Action                                                   01/00/05
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


Federal, Local, State, Tribal


Agency Contact:
Steven F. Witt
Director, Directorate of Standards and Guidance
Department of Labor
Occupational Safety and Health Administration
200 Constitution Avenue NW.
Room N-3718, FP Building
Washington, DC 20210
Phone: 202 693-1950
Fax: 202 693-1678
RIN: 1218-AA05
_______________________________________________________________________



DOL--OSHA



102. STANDARDS IMPROVEMENT (MISCELLANEOUS CHANGES) FOR GENERAL 
INDUSTRY, MARINE TERMINALS, AND CONSTRUCTION STANDARDS (PHASE II)
Priority:


Other Significant


Legal Authority:


29 USC 655(b)


CFR Citation:


29 CFR 1910, subpart Z; 29 CFR 1910.1001 to 1910.1052; 29 CFR 1910.142; 
29 CFR 1910.178; 29 CFR 1910.219; 29 CFR 1910.261; 29 CFR 1910.265; 29 
CFR 1910.410; 29 CFR 1917.92; 29 CFR 1926.1101; 29 CFR 1926.1127; 29 
CFR 1926.1129; 29 CFR 1926.60; 29 CFR 1926.62


Legal Deadline:


None


Abstract:


The Occupational Safety and Health Administration (OSHA) proposed to 
remove or revise provisions in its health standards that are out of 
date, duplicative, unnecessary, or inconsistent. Where appropriate, the 
Agency is primarily changing that provision to reduce the burden 
imposed on the regulated community by these requirements. In this 
document, substantive changes standards will revise or eliminate 
duplicative, inconsistent, or unnecessary regulatory requirements 
without diminishing employee protections. Phase I of this Standards 
Improvement process was completed in June 1998 (63 FR 33450). OSHA 
plans to initiate Phase III of this project at a future date to address 
problems in various safety and health standards.


Statement of Need:


Some parts of OSHA's standards are out of date, duplicative, 
unnecessary, or inconsistent. The Agency needs to periodically review 
its standards and make needed corrections. This effort results in 
standards that are easier for employers and employees to follow and 
comply with, and thus enhances compliance and worker protection.


Summary of Legal Basis:


The legal basis for the proposed rule is a preliminary finding that the 
OSHA standards need to be updated to bring them up to date, reduce 
inconsistency, and remove unneeded provisions.


Alternatives:


OSHA has considered updating each standard as problems are discovered, 
but has determined that it is better to make such changes to groups of 
standards so it is easier for the public to comment on like standards. 
OSHA has also considered the inclusion of safety standards that need to 
be updated. However, the Agency has decided to pursue a separate 
rulemaking for safety issues because the standards to be updated are of 
interest to different stakeholders.


Anticipated Cost and Benefits:


This revision of OSHA's standards is a deregulatory action. It will 
reduce employers' compliance obligations.


Risks:


The project does not address specific risks, but is intended to improve 
OSHA's standards by bringing them up to date and deleting unneeded 
provisions. The anticipated changes will have no negative effects on 
worker safety and health.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            67 FR 66493                                    10/31/02
NPRM Comment Period End                                        12/20/02
NPRM Comment Per68 FR 1023ed                                   01/08/03
Second NPRM Comment Period End                                 01/30/03
Public Hearing                                                 07/08/03
Final Action                                                   12/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Steven F. Witt
Director, Directorate of Standards and Guidance
Department of Labor
Occupational Safety and Health Administration
200 Constitution Avenue NW.
Room N-3718, FP Building
Washington, DC 20210
Phone: 202 693-1950
Fax: 202 693-1678
RIN: 1218-AB81

[[Page 72795]]

_______________________________________________________________________



DOL--Office of the Assistant Secretary for Veterans' Employment and 
Training (ASVET)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




103. UNIFORMED SERVICES EMPLOYMENT AND REEMPLOYMENT RIGHTS ACT 
REGULATIONS
Priority:


Other Significant


Legal Authority:


38 USC 4331(a)


CFR Citation:


20 CFR 1002


Legal Deadline:


None


Abstract:


The Secretary's commitment to protecting the employment rights of 
servicemembers as they return to the civilian work force is reflected 
by the initiative to promulgate regulations implementing the Uniformed 
Services Employment and Reemployment Rights Act of 1994 (USERRA) with 
regard to States, local governments and private employers. USERRA 
provides employment and reemployment protections for members of the 
uniformed services, including veterans and members of the Reserve and 
National Guard. The Department has not previously issued implementing 
regulations under USERRA, although the law dates back to 1994.


Statement of Need:


The Uniformed Services Employment and Reemployment Rights Act of 1994 
(USERRA), 38 U.S.C. 4301-4333, provides employment and reemployment 
rights for members of the uniformed services, including veterans and 
members of the Reserve and National Guard. Under USERRA, eligible 
service members who leave their civilian jobs for military service are 
entitled to return to reemployment with their previous employers with 
the seniority, status and rate of pay they would have attained had they 
not been away on duty. USERRA also assures that they will not suffer 
discrimination in employment because of their military service or 
obligations.


Following the attacks of September 11, 2001, the President authorized a 
major mobilization of National Guard and Reserve forces that has 
continued into 2004. In the past three years, the Department has 
experienced a tremendous increase in the number of inquiries about 
USERRA from employers and members of the Guard and Reserve. The high 
volume of requests for technical assistance indicates that there is a 
significant need for consistent and authoritative USERRA guidance. 
USERRA regulations will provide the Department's interpretations of the 
law and procedures for enforcing the law.


Summary of Legal Basis:


USERRA authorizes the Secretary of Labor, in consultation with the 
Secretary of Defense, to issue regulations implementing USERRA with 
regard to States, local governments and private employers. 38 U.S.C. 
4331(a).


Alternatives:


In lieu of regulations, the Department could choose to continue its 
compliance assistance efforts, and could issue interpretations of 
USERRA in the form of a USERRA Handbook, policy memoranda or other less 
formal means. These would not benefit from broad-based public input, 
nor would they receive the same level of deference as regulations. See 
United States v. Mead Corp., 533 U.S. 218, 230 (2001).


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            69 FR 56266                                    09/20/04
NPRM Comment Period End                                        11/19/04
Final Action                                                   06/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses, Governmental Jurisdictions, Organizations


Government Levels Affected:


Local, State


Agency Contact:
Robert Wilson
Chief, Investigation and Compliance Division
Department of Labor
Office of the Assistant Secretary for Veterans' Employment and Training
200 Constitution Avenue NW.
Room S-1316
Washington, DC 20210
Phone: 202 693-4719
Fax: 202 693-4755
RIN: 1293-AA09
BILLING CODE 4510-23-S

[[Page 72796]]




DEPARTMENT OF TRANSPORTATION (DOT)



Statement of Regulatory Priorities
 The Department of Transportation (DOT) consists of nine operating 
administrations, the Bureau of Transportation Statistics, and the 
Office of the Secretary, each of which has statutory responsibility for 
a wide range of regulations. For example, DOT regulates safety in the 
aviation, motor carrier, railroad, mass transit, motor vehicle, 
commercial space, and pipeline transportation areas. DOT regulates 
aviation consumer and economic issues and provides financial assistance 
and writes the necessary implementing rules for programs involving 
highways, airports, mass transit, the maritime industry, railroads, and 
motor vehicle safety. It writes regulations carrying out such disparate 
statutes as the Americans with Disabilities Act and the Uniform Time 
Act. Finally, DOT has responsibility for developing policies that 
implement a wide range of regulations that govern internal programs 
such as acquisition and grants, access for the disabled, environmental 
protection, energy conservation, information technology, occupational 
safety and health, property asset management, seismic safety, and the 
use of aircraft and vehicles.
 The Department has adopted a regulatory philosophy that applies to all 
its rulemaking activities. This philosophy is articulated as follows: 
DOT regulations must be clear, simple, timely, fair, reasonable, and 
necessary. They will be issued only after an appropriate opportunity 
for public comment, which must provide an equal chance for all affected 
interests to participate, and after appropriate consultation with other 
governmental entities. The Department will fully consider the comments 
received. It will assess the risks addressed by the rules and their 
costs and benefits, including the cumulative effects. The Department 
will consider appropriate alternatives, including nonregulatory 
approaches. It will also make every effort to ensure that legislation 
does not impose unreasonable mandates.
 An important initiative of Secretary Mineta's has been to increase the 
timeliness of DOT rulemaking actions and address the large number of 
old rulemakings. To implement this, the Secretary has required (1) 
regular meetings of senior DOT officials to ensure effective scheduling 
of rulemakings and timely decisions, (2) better tracking and 
coordination of rulemakings, (3) regular reporting, (4) early briefings 
of interested officials, (5) better training of staff, and (6) 
necessary resource allocations. The Department has achieved significant 
success as a result of this initiative with the number of old 
rulemakings as well as the average time to complete rulemakings 
decreasing. This is also allowing the Department to use its resources 
more effectively and efficiently.
 The Department's regulatory policies and procedures provide a 
comprehensive internal management and review process for new and 
existing regulations and ensure that the Secretary and other 
appropriate appointed officials review and concur in all significant 
DOT rules. DOT continually seeks to improve its regulatory process. The 
Department's development of regulatory process and related training 
courses for its employees; creation of an electronic, Internet-
accessible docket that can also be used to submit comments 
electronically; a ``list serve'' that allows the public to sign up for 
e-mail notification when the Department issues a rulemaking document; 
creation of an electronic rulemaking tracking and coordination system; 
the use of direct final rulemaking; and the use of regulatory 
negotiation are a few examples of this.
 In addition, the Department continues to engage in a wide variety of 
activities to help cement the partnerships between its agencies and its 
customers that will produce good results for transportation programs 
and safety. The Department's agencies also have established a number of 
continuing partnership mechanisms in the form of rulemaking advisory 
committees.
 The Department is also actively engaged in the review of existing 
rules to determine whether they need to be revised or revoked. These 
reviews are in accordance with section 610 of the Regulatory 
Flexibility Act, the Department's regulatory policies and procedures, 
and Executive Order 12866. This includes determining if the rules would 
be more understandable if they are written using a plain language 
approach. Appendix D to our Regulatory Agenda highlights our efforts in 
this area.
 Over the next year, the Department will continue its efforts to use 
advances in technology to improve its rulemaking management process. 
For example, the Department created an effective tracking system for 
significant rulemakings to ensure that rules are either completed in a 
timely manner or that delays are identified and fixed. Through this 
tracking system, a monthly report is generated. To make its efforts 
more transparent, the Department has made this report Internet-
accessible. By doing this, the Department is providing valuable 
information concerning our rulemaking activity and is providing 
information necessary for the public to evaluate the Department's 
progress in meeting its commitment to completing rulemakings in a 
timely manner.
 The Department will continue to place great emphasis on the need to 
complete high quality rulemakings by involving senior Departmental 
officials in regular meetings to resolve issues expeditiously.
Office of the Secretary of Transportation (OST)
 The Office of the Secretary (OST) oversees the regulatory process for 
the Department. OST implements the Department's regulatory policies and 
procedures and is responsible for ensuring the involvement of top 
management in regulatory decisionmaking. Through the General Counsel's 
office, OST is also responsible for ensuring that the Department 
complies with Executive Order 12866 and other legal and policy 
requirements affecting rulemaking, including new statutes and Executive 
orders. Although OST's principal role concerns the review of the 
Department's significant rulemakings, this office has the lead role in 
the substance of projects concerning aviation economic rules and those 
affecting the various elements of the Department.
 OST provides guidance and training regarding compliance with 
regulatory requirements and process for use by personnel throughout the 
Department. OST also plays an instrumental part in the Department's 
efforts to improve our economic analyses, risk assessments, and 
regulatory flexibility analyses.
 OST also leads and coordinates the Department's response to 
Administration and congressional proposals that concern the regulatory 
process. The General Counsel's Office works closely with 
representatives of other agencies, the Office of Management and Budget, 
the White House, and congressional staff to provide information on how 
various proposals would affect the ability of the Department to perform 
its safety, infrastructure, and other missions.
 During fiscal year 2005, OST expects to complete work on an NPRM that 
will propose accessibility requirements for vessels which involves 
complex issues

[[Page 72797]]

unlike those affecting land transportation. This NPRM will propose 
feasible requirements to make passenger vessels accessible to, and 
usable by, individuals with disabilities.
Federal Aviation Administration (FAA)
 The FAA issues regulations to provide a safe, secure, and efficient 
global aviation system for civil aircraft. In an effort to make sure 
their rules are concise and easy to understand, the FAA reexamined the 
use of plain language in its regulations. The initial result of this 
review was revisions to 14 CFR part 11, which delineates the process 
for rulemaking changes. We have extended this initiative to include 
plain language revisions to our regulatory documents, advisory 
material, handbook guidance, and all reports and correspondence we 
prepare. Other actions include:
 Supporting the FAA's Safety Agenda on Safer Skies. This agenda is 
based on a comprehensive review of the causes of aviation accidents and 
is designed to bring about an 80 percent reduction in fatal accidents. 
Projects related to controlled flight into terrain, loss of control of 
an aircraft, uncontained engine failures, runway incursions, weather, 
pilot decisionmaking, and cabin safety are some of the focus areas 
identified that may result in rulemaking advisory and guidance 
materials.
 Continuing to involve the aviation community early in the regulatory 
process. The Aviation Rulemaking Advisory Committee (ARAC) completed 
numerous reports and recommendations, leading to the publication of 
seven regulatory actions and issuance of several advisory circulars and 
other guidance materials. The FAA Aging Transport Nonstructural Systems 
Plan addresses concerns with potential safety issues associated with 
problems that may develop in transport category airplanes systems as a 
result of wear and degradation in service. One important component of 
the plan is use of the Aging Transport Nonstructural Systems Rulemaking 
Advisory Committee to provide a mechanism for public input to FAA 
activities. The FAA will continue to receive recommendations from the 
Committee in the form of regulations, guidance materials, and training 
requirements supporting enhanced airworthiness for airplane systems.
 Continuing to harmonize the U.S. aviation regulations with those of 
other countries. The harmonization of the U.S. regulations with the 
European Joint Aviation Regulations is the FAA's most comprehensive 
long-term rulemaking effort. The differences worldwide in certification 
standards, practice and procedures, and operating rules must be 
identified and minimized to reduce the regulatory burden on the 
international aviation system. The differences between the FAA 
regulations and the requirements of other nations impose a heavy burden 
on U.S. aircraft manufacturers and operations. Harmonization and 
standardization should help the U.S. aerospace industry remain 
internationally competitive. While the overall effort to achieve this 
is global, it will be accomplished by many small, individual, 
nonsignificant rulemaking projects. The FAA has published 41 
regulations based on recommendations of ARAC that will lead to 
harmonizing FAA regulations and Joint Aviation Requirements.
 Continuing to recognize the needs of small entities by complying with 
the Small Business Regulatory Enforcement Fairness Act and addressing 
small entity concerns whenever appropriate in rulemaking documents. In 
response to the Act, the FAA has established a Small Entity Contact, a 
website on FAA's home page, a toll-free number, and an e-mail address 
for receipt of inquiries.
 Ensuring that the congressional mandates for rulemaking deadlines 
established by the FAA Reauthorization Act of 1996 are met. One mandate 
is the issuance of a final rule 16 months after the close of the 
comment period on the proposed rule.
 Top regulatory priorities for 2004-2005 include a final rule 
concerning flight simulation device requirements and several rulemaking 
projects known collectively as the FAA's Aging Airplane Program. The 
FAA developed the Aging Airplane Program to address structural and non-
structural system safety issues that may arise as airplanes age and in 
response to:
 Airplanes being operated beyond their original designservice 
            goals;
 The 1988 Aloha B737 accident; and
 The Aging Airplane Safety Act of 1991.
 The rulemakings included in the Aging Airplane Program are:
 Enhanced Airworthiness Program for Aging Systems/FuelTank 
            Safety;
 Development of Type Certificate and Supplemental 
            TypeCertificate Holder Data for the Aging Aircraft Safety 
            Program; and
 Widespread Fatigue Damage Program.
 Other related rulemakings include withdrawal of a notice of proposed 
rulemaking on Corrosion Prevention and Control Program (69 FR 50350, 
August 16, 2004) and taking final action on the Aging Airplane Safety 
Interim Final Rule issued on December 6, 2002.
 We recently performed a comprehensive review of our Aging Airplane 
Program and published for public comment an overview of our findings 
(69 FR 45936, July 30, 2004).
Federal Highway Administration (FHWA)
 The FHWA will continue with ongoing regulatory initiatives in support 
of its surface transportation programs. The FHWA will continue to 
implement legislation in the least burdensome and restrictive way 
possible consistent with the FHWA's mission. The FHWA will continue to 
pursue regulatory reform in areas where project development can be 
streamlined or accelerated, duplicative requirements can be 
consolidated, recordkeeping requirements can be reduced or simplified, 
and the decisionmaking authority of our State and local partners can be 
increased.
Federal Motor Carrier Safety Administration (FMCSA)
 FMCSA commenced operations on January 2, 2000, pursuant to the Motor 
Carrier Safety Improvement Act of 1999 (MCSIA) (Public Law 106-159), as 
codified at 49 U.S.C. section 113, to improve the administration of the 
Federal motor carrier safety program. The agency's primary mission is 
to reduce crashes, injuries, and fatalities involving large trucks and 
buses. DOT set a safety goal for all its surface transportation 
agencies to reduce the fatality rate by 41 percent during the period 
from 1996 to 2008. FMCSA has been working to achieve a goal of reducing 
the number of large truck- and bus-involved fatalities by 41 percent, 
or a reduction to no more than 1.65 commercial motor vehicle (CMV) 
fatalities per 100 million truck vehicle miles traveled by the end of 
2008. Although any life lost in a traffic crash is too many, FMCSA will 
strive to meet and exceed this safety goal. For example, regulations 
relating to performance standards for vehicles, drivers, and motor 
carriers will help achieve this goal. In MCSIA, Congress put special 
emphasis on the importance of timely rulemaking as a way to achieve 
reductions in the number and severity of large truck-involved crashes. 
FMCSA continues to develop a more effective and efficient regulatory 
program to meet the expectations of

[[Page 72798]]

Congress, its stakeholders and partners, and the general public. To 
improve both the quality and timeliness of the agency's rulemakings, 
FMCSA established a rulemaking process for the development of its motor 
carrier safety regulations and updates it periodically.
 In fiscal year 2004, FMCSA completed four final rules pursuant to the 
settlement agreement entered into by the parties and the court's order 
In re Citizens for Reliable and Safe Highways, et al., No. 02-1363 
(D.C. Cir.) (February 21, 2003): Safety Performance History of New 
Drivers (69 FR 16684, 03/30/2004); Minimum Training Requirements for 
Longer Combination Vehicle (LCV) Operators and LCV Driver-Instructor 
Requirements (69 FR 16722, 03/30/2004); Minimum Training Requirements 
for Entry-Level Commercial Motor Vehicle Operators (69 FR 29384, 05/21/
2004); and Hazardous Materials Safety Permits (69 FR 39350, 06/30/
2004). FMCSA also published implementing procedures covering its 
obligations under the National Environmental Policy Act (69 FR 9680, 
03/01/2004).
 On September 30, Congress passed and the President signed HR 5183, an 
extension of the surface transportation program authorizations which 
addressed the Hours of Service (HOS) rule announced by FMCSA in April 
2003. The action by Congress means the new hours-of-service rule stays 
in effect and will be enforced until September 30, 2005, or until such 
earlier time as FMCSA issues a revised rule addressing the concerns of 
the U.S. Court of Appeals for the District of Columbia Circuit stated 
in Public Citizen et al. v. FMCSA. FMCSA has issued an ANPRM on 
Electronic On-Board Recorders (EOBRs) under RIN 2126-AA89 as part of 
its efforts to meet the concerns of the Court.
 As one of its priorities in fiscal year 2005, FMCSA has announced that 
it is holding a series of Public Listening Sessions as part of a 
Comprehensive Safety Analysis 2010 Initiative (CSA-2010). The listening 
sessions will be used to ask motor carriers, insurance and safety 
advocacy groups, traffic enforcement professionals, commercial drivers 
and the public for their views on the ideal ways to measure the safety 
of truck and bus operations (69 FR 51748, 08/20/2004). Based on the 
information from the listening sessions, FMCSA hopes to redesign and 
improve the way FMCSA conducts compliance and enforcement operations, 
and to help in its goal of decreasing CMV fatalities to no more than 
1.65 per 100 million miles by the end of 2008.
 Other FMCSA priorities in 2005 are a rulemaking that involves 
combining the medical certification with the commercial driver's 
license (the last remaining MCSIA initiative); rulemakings directed at 
strengthening our enforcement activities; and a number of rulemakings 
related to operational safety.
National Highway Traffic Safety Administration (NHTSA)
 The statutory responsibilities of the National Highway Traffic Safety 
Administration (NHTSA) relating to motor vehicles include reducing the 
number of, and mitigating the effects of, motor vehicle crashes and 
related fatalities and injuries; providing safety performance 
information to aid prospective purchasers of vehicles, child 
restraints, and tires; and improving automotive fuel efficiency. NHTSA 
pursues policies that encourage the development of nonregulatory 
approaches when feasible in meeting its statutory mandates. It issues 
new standards and regulations or amendments to existing standards and 
regulations when appropriate. It ensures that regulatory alternatives 
reflect a careful assessment of the problem, consideration of 
international standards and harmonization objectives, and a 
comprehensive analysis of the benefits, costs, and other impacts 
associated with the proposed regulatory action. Finally, it considers 
alternatives consistent with the Administration's regulatory 
principles.
 In the coming year, occupant protection in rear-end crashes will be 
improved as a result of a final rule to require more effective head 
restraints. Rear seat occupants, especially children, will be better 
protected in crashes because of a final rule to require rear center 
lap/shoulder belts. NHTSA will propose to alert vehicle owners by a new 
Tire Pressure Monitoring System in cars and light trucks when the 
vehicle's tires are significantly underinflated. The agency will take 
final action on this proposal before September 30, 2005.
 In addition to numerous programs that focus on the safe performance of 
motor vehicles, the Agency is engaged in a variety of programs to 
improve driver and occupant behavior. These programs emphasize the 
human aspects of motor vehicle safety and recognize the important role 
of the States in this common pursuit. NHTSA has identified two high 
priority areas, safety belt use and impaired driving. In 2003, it 
released a report analyzing safety belt use problems and describing 
actions to address them. A separate report analyzed and described 
actions to address the problem of impaired driving. To address this 
problem, the Agency is focusing especially on three strategies -- 
conducting highly visible, well publicized enforcement; supporting 
prosecutors who handle impaired driving cases and expanding the use of 
DWI/Drug Courts, which hold offenders accountable for receiving and 
completing treatment for alcohol abuse and dependency; and the adoption 
of alcohol screening and brief intervention by medical and health care 
professionals. Other behavioral efforts encourage child safety-seat 
use, combat excessive speed and aggressive driving, improve motorcycle, 
bicycle, and pedestrian safety, and provide consumer information to the 
public.
Federal Railroad Administration (FRA)
 The Federal Railroad Administration (FRA) exercises 
regulatoryauthority over all areas of railroad safety. Fashioning 
regulations that have favorable benefit-to-cost ratios and that, where 
feasible, incorporate flexible performance standards, requires 
cooperative action by all affected parties. In order to foster an 
environment of collaborative rulemaking, FRA established the Railroad 
Safety Advisory Committee (RSAC). The purpose of the RSAC is to develop 
consensus recommendations for regulatory action on issues referred to 
it by FRA. Where consensus is achieved, and FRA believes the consensus 
recommendations serve the public interest, the resulting rule is very 
likely to be better understood, more widely accepted, more cost-
beneficial, and more correctly applied. Where consensus cannot be 
achieved, however, FRA will fulfill its regulatory role without the 
benefit of the RSAC's recommendations. The RSAC has met regularly and 
currently has working groups actively addressing the following tasks: 
(1) The development of safety standards for locomotive crashworthiness; 
(2) the development of safety standards for locomotive working 
conditions, including occupational noise exposure; and (3) the 
development of accident survivability standards for locomotive event 
recorders. FRA is also completing a rulemaking based on the RSAC's 
recommendations entitled ``Performance Standards for Processor-Based 
Signal and Train Control Systems.'' Further, at FRA's request the RSAC 
is conducting a preliminary exploration of further opportunities for 
improvement of the safety of rail

[[Page 72799]]

passenger service that might lead to recommendations for public or 
private actions.
 One of the top priorities of FRA for 2004-2005 is a final rule 
concerning whistle bans at highway-rail grade crossings.
Federal Transit Administration (FTA)
 The Federal Transit Administration (FTA) provides financial assistance 
to State and local governments for mass transportation purposes. The 
regulatory activity of FTA focuses on establishing the terms and 
conditions of Federal financial assistance available under the Federal 
transit laws.
 FTA's policy regarding regulations is to:
 Implement statutory authorities in ways that provide the 
            maximum net benefits to society;
 Keep paperwork requirements to a minimum;
 Allow for as much local flexibility and discretion as is 
            possible within the law;
 Ensure the most productive use of limited Federal resources;
 Protect the Federal interest in local investments; and
 Incorporate good management principles into the grant 
            management process.
 As mass transportation needs have changed over the years, so have the 
requirements for Federal financial assistance under the Federal transit 
laws and related statutes. FTA's regulatory priorities for 2004-2005 
are to continue to amend existing regulations as necessary and 
appropriate, with an eye towards reauthorization of the Federal transit 
programs in the near future, which may require several significant 
rulemakings thereafter.
Maritime Administration (MARAD)
 MARAD administers Federal laws and programs designed to promote and 
maintain a U.S. merchant marine capable of meeting the Nation's 
shipping needs for both national security and domestic and foreign 
commerce.
 MARAD's regulatory objectives and priorities reflect the Agency's 
responsibility of ensuring the availability of adequate and efficient 
water transportation services for American shippers and consumers. To 
advance these objectives, MARAD issues regulations, which are 
principally administrative and interpretive in nature, when 
appropriate, in order to provide a net benefit to the U.S. maritime 
industry.
 MARAD's regulatory priorities are to update existing regulations and 
to reduce unnecessary burden on the public.
Research and Special Programs Administration (RSPA)
 The Research and Special Programs Administration (RSPA) has 
responsibility for rulemaking under two programs. Through the Associate 
Administrator for Hazardous Materials Safety, RSPA administers 
regulatory programs under Federal hazardous materials transportation 
law and the Federal Water Pollution Control Act, as amended by the Oil 
Pollution Act of 1990. Through the Associate Administrator for Pipeline 
Safety, RSPA administers regulatory programs under the Federal pipeline 
safety laws and the Federal Water Pollution Control Act, as amended by 
the Oil Pollution Act of 1990.
 In the area of hazardous materials transportation, the regulatory 
priority is to clarify through rulemaking the applicability of 
regulations to the loading, unloading, and storage of hazardous 
materials incidental to their movement in commerce. Clarifying the 
applicability of the regulations will facilitate compliance with them 
and also clarify when other requirements of Federal, State, local, and 
tribal governments apply.
Bureau of Transportation Statistics (BTS)
 The Bureau of Transportation Statistics (BTS) is responsible for 
collecting, compiling, analyzing, and making accessible information on 
the Nation's transportation systems; identifying needs for new 
information and analysis and implementing programs to meet those needs; 
and enhancing the quality and effectiveness of the Department's 
statistical programs through the development of guidelines, 
coordination with related information-gathering activities conducted by 
other Federal agencies, and promotion of improvements in data 
acquisition, archiving, dissemination, and use.
 BTS's Office of Airline Information (OAI) collects airline financial 
and operating statistical data, covering both passenger and cargo 
traffic. This information gives the Government consistent and 
comprehensive economic and market data on individual airline operations 
and is used, for instance, in supporting policy initiatives, 
negotiating international bilateral aviation agreements, awarding 
international route authorities, and meeting international treaty 
obligations. The aviation, travel, and tourism communities value this 
information for a variety of purposes, such as conducting analyses of 
on-time performance, denied boardings, market trends, and economic 
analyses.
Saint Lawrence Seaway Development Corporation (SLSDC)
 The Saint Lawrence Seaway Development Corporation (SLSDC) is a wholly 
owned Government corporation created by Congress in 1954. The primary 
operating service of the SLSDC is to ensure the safe transit of 
commercial and noncommercial vessels through the two U.S. locks and 
navigation channels of the Saint Lawrence Seaway System. The SLSDC 
works jointly with its Canadian counterpart to operate and maintain 
this deep draft waterway between the Great Lakes and the Atlantic 
Ocean. The SLSDC also works jointly with its Canadian counterpart on 
all matters related to rules and regulations, overall operations, 
vessel inspection, traffic control, navigation aids, safety, operating 
dates, and trade development programs.
The regulatory priority of the SLSDC is to provide its customers with 
the safest, most reliable, and most efficient Seaway System possible.
_______________________________________________________________________



DOT--Federal Aviation Administration (FAA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




104. [rplus]AGING AIRCRAFT PROGRAM (WIDESPREAD FATIGUE DAMAGE)
Priority:


Other Significant


Legal Authority:


49 USC 106(g); 49 USC 40113; 49 USC 40119; 49 USC 41706; . . .


CFR Citation:


14 CFR 121; 14 CFR 129


Legal Deadline:


None


Abstract:


The FAA proposes to require incorporation of a program to preclude 
widespread fatigue damage into the FAA-approved maintenance program of

[[Page 72800]]

each operator of large transport category airplanes. This action is the 
result of concern for the continued operational safety of airplanes 
that are approaching or have exceeded their design service goal. This 
proposed rulemaking would require a limit of validity in flight cycles 
or hours of the structural maintenance program, where the operator must 
incorporate added inspections and/or modification/replacement actions 
into its maintenance program to allow continued operation.


Statement of Need:


History has shown that widespread fatigue damage is a significant 
safety risk for transport category airplanes. The Aloha B-737 accident 
in 1988 showed FAA and industry that WFD could be a problem that could 
lead to catastrophic failure of airplane structure. Numerous widespread 
fatigue damage incidents since then have confirmed that it is a threat 
common to all aging airplanes. Because widespread fatigue damage 
results from the interaction of many small cracks, existing inspection 
methods are inadequate to reliably detect and prevent it.


Summary of Legal Basis:


Section 44701, Title 49 of the United States Code states that the 
Administrator shall promote safety of flight of civil aircraft in air 
commerce by prescribing minimum standards required in the interest of 
safety.


Alternatives:


The FAA acknowledges the proposed rule may have a significant impact on 
a substantial number of small entities. We conclude the current 
proposal is the preferred alternative because it provides for a common 
WFD system for all operators who fly in the same airspace under the 
same operating environment.


We considered the following alternatives:


1.Exclude small entities


2.Extend the compliance deadline for small entities


3.Establish lesser technical requirements for small entities


4.Expand the requirements to cover more airplanes


Anticipated Cost and Benefits:


The cost of this proposal is $358.1 million. The benefits of this 
proposal consist of $654 million in accident prevention benefits and 
$74 million in detection benefits, for total benefits of $728 million.


Risks:


Because widespread fatigue damage problems will occur as airplanes 
operate beyond their initial operational limit, operators are likely to 
detect such problems over the 20-year forecast period. The FAA has 
assumed that there is a probability of widespread fatigue damage 
problems occurring for each fuselage type of five percent in each year. 
Under this assumption, there is a 35 percent chance that there will be 
zero WFD problems detected for a particular fuselage type over a 20-
year period.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           05/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


URL For More Information:
dms.dot.gov
URL For Public Comments:
dms.dot.gov
Agency Contact:
Brent Bandley
Department of Transportation
Federal Aviation Administration
3960 Paramount Boulevard
Lakewood, CA 90712
Phone: 562 627-5237
RIN: 2120-AI05
_______________________________________________________________________



DOT--FAA



105. [rplus]ENHANCED AIRWORTHINESS PROGRAM FOR AIRPLANE SYSTEMS (EAPAS) 
AND SFAR 88
Priority:


Other Significant


Legal Authority:


49 USC 106(g); 49 USC 1155; 49 USC 1372; 49 USC 40103; 49 USC 40119; 49 
usc 40120; 49 USC 106(g); 49 USC 40103; 49 USC 40113; 49 USC 40119 to 
40120; 49 USC 41706; 49 USC 4401; 49 USC 44111; 49 USC 44701 to 44705; 
49 USC 44709 to 44713; 49 USC 44715 to 44717


CFR Citation:


14 CFR 1; 14 CFR 25; 14 CFR 91; 14 CFR 121; 14 CFR 125; 14 CFR 129; 14 
CFR 1; 14 CFR 121; 14 CFR 129; 14 CFR 25; 14 CFR 91


Legal Deadline:


None


Abstract:


This rulemaking would change wiring system and fuel tank system 
requirements for transport category airplanes. It would organize and 
clarify design requirements for wire systems by moving existing 
regulatory references to wiring into a single section of the 
regulations specifically for wiring and adding new certification rules 
to address aging issues in wire systems. This rulemaking would require 
holders of type certificates for certain transport category airplanes 
to conduct analyses and make necessary changes to existing Instruction 
for Continued Airworthiness (ICA) to improve maintenance procedures for 
wire systems. It would require operators to incorporate those ICA for 
wiring into their maintenance or inspections programs. It would also 
clairfy requirements of certain existing operational rules for 
operators to incorporate ICA for fuel tank systems into their 
maintenance or inspection programs. The intent of this rule is to help 
ensure the continued safety of commercial airplanes by improving the 
design, installation, and maintenance of their electrical wiring 
systems as well as by aligning those requirements as closely as 
possible with the requirements for fuel tank system safety.


Statement of Need:


The proposal will address a continuing history of wire-related 
failures, resulting in smoke in the cabin/flight deck, fires, arcing 
etc. Current maintenance practices have not been adequate to address 
issues of aging and degradation in wiring. Wires have not been viewed 
as important systems on their own.


Summary of Legal Basis:


Section 44701, title 49 of the United States Code states that the 
Administrator shall promote safety of flight of civil aircraft in air 
commerce by prescribing minimum standards required in the interest of 
safety.


Alternatives:


1. Require operators to clean and inspect each airplane every C-check 
or every three years, causing an additional

[[Page 72801]]

$192.5 million in cleaning and inspection costs, and an additional 
$104.0 million in downtime. This option would result in additional 
costs of $296.5 million with no commensurate increase in benefits.


2. Require electrical wiring interconnection systems training for four 
new groups of people (electrical/avionic engineers, individuals 
involved in engineering or planning work, flight deck crew, and cabin 
crew) in addition to maintenance workers. Training these individuals 
would require that operators develop additional courses. The total 
estimated additional cost of this alternative is approximately $381.1 
million with no commensurate increase in benefits.


3. We also considered voluntary compliance with the intent of this 
proposal by the affected parties. Some in industry have suggested 
issuing advisory circulars to give guidance on changes that need to be 
made. However, previous voluntary safety assessments have been 
difficult to complete in a timely manner because they lack 
enforceability. Similarly, issuance of guidance material would depend 
on voluntary compliance, and would not be enforceable.


Anticipated Cost and Benefits:


Total costs are estimated at $474.3 million ($209.2 million in present 
value) over 25 years. Total benefits are estimated at $755.3 million 
($340.7 million in present value) over 25 years.


Risks:


The FAA estimates there may be more than 1.2 fatal events caused by 
electrical wiring interconnection systems (EWIS) over a 25-year period. 
The Poisson distribution provides a measure for this risk. Based on a 
mean value of 1.2 fatal EWIS events, there is a 70 percent chance there 
will be 1 or more occurrences of a fatal EWIS event, a 34 percent 
chance there will be 2 or more fatal EWIS events; and a 12 percent 
chance of 3 or more occurrences of fatal EWIS events.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           04/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


URL For More Information:
dms.dot.gov
URL For Public Comments:
dms.dot.gov
Agency Contact:
Frederick Sobeck
Aircraft Maintenance Division, Flight Standards Service
Department of Transportation
Federal Aviation Administration
800 Independence Avenue SW.
Washington, DC 20591
Phone: 202 267-7355
Fax: 202 267-7335
Email: [email protected]

Stephen M. Slotte
Aircraft Certification Service
Department of Transportation
Federal Aviation Administration
1601 Lind Avenue SW.
Renton, WA 98055-2315
Phone: 425 227-2315
Fax: 425 227-1320
Email: [email protected]
RIN: 2120-AI31
_______________________________________________________________________



DOT--FAA



106. [rplus]AGING AIRCRAFT SAFETY--DEVELOPMENT OF TC AND STC HOLDER 
DATA
Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


This action may affect State, local or tribal governments and the 
private sector.


Legal Authority:


49 USC 106(g); 49 USC 40113; 49 USC 44701; 49 USC 44702; 49 USC 44704


CFR Citation:


14 CFR 25


Legal Deadline:


None


Abstract:


This rulemaking would require type certificate holders and supplemental 
type certificate holders of certain transport category airplanes to 
develop data to support damage-tolerance-based inspections and 
procedures for their airplanes' baseline structure, including repairs, 
alterations and modifications to the baseline structure. It would also 
help ensure that maintenance of the airplanes age sensitive parts and 
components have been adequate and timely. These actions are needed to 
assure that 14 CFR part 121 certificate holders have the necessary data 
to comply with the damage tolerance requirements of the Aging Airplane 
Safety rule.


Statement of Need:


In several recent rules the FAA has adopted operational requirements 
without a corresponding requirement for design approval holders to 
develop and provide the necessary data and documents to support 
operator compliance. The difficulty encountered by operators in 
complying with these rules has convinced us that corresponding design 
approval holder requirements are necessary to enable operators to 
comply by the regulatory deadlines.


Summary of Legal Basis:


Section 44704, title 49 of the United States Code states that the 
Administrator shall promote safety of flight of civil aircraft in air 
commerce by prescribing minimum standards required in the interest of 
safety.


Alternatives:


Issuance of guidance material would depend on voluntary compliance, and 
would not be enforceable.


Anticipated Cost and Benefits:


Not yet determined.


Risks:


Without a regulatory requirement imposed on design approval holders, 
operators would have to rely on voluntary compliance by design approval 
holders to provide data operators needed to comply with the regulatory 
requirement to develop damage tolerance programs required by the Aging 
Airplane Safety rule.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           09/00/05
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


Federal, Local, State


Federalism:


 This action may have federalism implications as defined in EO 13132.


URL For More Information:
dms.dot.gov
URL For Public Comments:
dms.dot.gov

[[Page 72802]]

Agency Contact:
Greg Schneider
Department of Transportation
Federal Aviation Administration
1601 Lind Avenue SW
Renton, WA 98055
Phone: 425 227-2116
Fax: 425-227-1181
Email: [email protected]
RIN: 2120-AI32
_______________________________________________________________________



DOT--FAA

                              -----------

                            FINAL RULE STAGE

                              -----------




107. [rplus]FLIGHT SIMULATION DEVICE QUALIFICATION (SECTION 610 REVIEW)
Priority:


Other Significant


Legal Authority:


49 USC 106(g); 49 USC 40113; 49 USC 44701 to 44703; 49 USC 44707; 49 
USC 44709; 49 USC 44711; 49 USC 45102 to 45103; 49 USC 45301 to 45302


CFR Citation:


14 CFR 1; 14 CFR 11; 14 CFR 60; 14 CFR 61; 14 CFR 63; 14 CFR 141; 14 
CFR 142


Legal Deadline:


None


Abstract:


This action will amend the regulations establishing flight simulation 
device qualification requirements for all certificate holders in a new 
part. The basis of these requirements currently exists in different 
parts of the FAA's regulation and in advisory circulars. The proposed 
changes would consolidate and update flight simulation device 
requirements.


Statement of Need:


It is important to consolidate and update flight simulation device 
requirements to ensure that users of flight simulation devices receive 
the best possible training in devices that closely match the 
performance and handling characteristics of the aircraft being 
simulated.


Summary of Legal Basis:


Section 44701, title 49 of the United States Code states that the 
Administrator shall promote safety of flight of civil aircraft in air 
commerce by prescribing minimum standards required in the interest of 
safety.


Alternatives:


The FAA chartered an Aviation Rulemaking Committee to develop 
alternative rule language to Notice No. 02-11.


Anticipated Cost and Benefits:


The FAA has placed a Draft Regulatory Evaluation of the NPRM in the 
docket.


Risks:


The purpose of this rulemaking is to ensure that users of flight 
simulation devices receive the best possible training in devices that 
closely match the performance and handling characteristics of the 
aircraft being simulated.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            67 FR 20284                                    09/25/02
NPRM Comment Per67 FR 69149d                                   11/15/02
Notice of On-Lin67 FR 70184rum                                 11/21/02
NPRM Comment Period End                                        12/24/02
NPRM Extended Comment Period End                               02/24/03
Final Action                                                   06/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


URL For More Information:
dms.dot.gov
URL For Public Comments:
dms.dot.gov
Agency Contact:
Edward Cook
Flight Standards Service
Department of Transportation
Federal Aviation Administration
100 Hartsfield Centre Parkway
Suite 400
Atlanta, GA 30354
Phone: 404 832-4700
RIN: 2120-AH07
_______________________________________________________________________



DOT--FAA



108. [rplus]TRANSPORT AIRPLANE FUEL TANK FLAMMABILITY REDUCTION
Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


This action may affect State, local or tribal governments and the 
private sector.


Legal Authority:


49 USC 106(g); 49 USC 40113; 49 USC 44701-44702; 49 USC 44704


CFR Citation:


14 CFR 25


Legal Deadline:


None


Abstract:


This rulemaking will require that flammability reduction means be 
incorporated into existing airplanes, newly manufactured airplanes, and 
new designs. It proposes new design standards for future and pending 
applications for type certification as well as new operating rules for 
retrofitting existing airplanes.


Statement of Need:


There have been four accidents caused by fuel tank explosions since 
1989. Two occurred during flight and two others occurred on the ground. 
Terrorists caused one of the four. In the other three cases, no 
ignition source was identified as the cause of the explosion. In all 
four cases, however, investigators concluded that the center wing fuel 
tank in these airplanes contained flammable vapors when the fuel tanks 
exploded and the accidents occurred.


Summary of Legal Basis:


Section 44701, title 49 of the United States Code states that the 
Administrator shall promote safety of flight of civil aircraft in air 
commerce by prescribing minimum standards required in the interest of 
safety.


Alternatives:


1. Require flammability reduction means on new production and new 
designs without requiring retrofit. The risk analysis for this option 
predicted an unacceptable high number of future accidents due to the 
high number of airplanes within the current fleet that would remain in 
service for many years.


2. Require inerting of all fuel tanks on existing airplanes in the 
fleet and new type designs.


3. Exclude all cargo operators.


4. Address unsafe condition through airworthiness directive.

[[Page 72803]]

5. Impose changes on operators as opposed to requiring OEMs to develop 
design changes.


Past experience on similar safety initiatives shows the OEMs do not 
consistently support these effors and places in undue burden on the 
operators.


Anticipated Cost and Benefits:


The FAA is conducting a regulatory evaluation using various 
combinations of the value of a human life, the timing of the next 
accidents, the passenger load on the next accident airplane, and the 
effectiveness of SFAR 88. We anticipate costs and benefits will vary 
based upon assumptions used in calculating these values. Using a value 
of 3 million per life, average airplane size, average time for the next 
accident, the costs could exceed $1 billion and quantitative benefits 
will be less than $1 billion.


Risks:


The FAA believes at least one and as many as five accidents will happen 
in the next 50 years.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Final Action                                                   12/00/04
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Federal, Local, State


Federalism:


 This action may have federalism implications as defined in EO 13132.


URL For More Information:
dms.dot.gov
URL For Public Comments:
dms.dot.gov
Agency Contact:
Mike Dostert
Transport Airplane Directorate, Aircraft Certification Service
Department of Transportation
Federal Aviation Administration
Northwest Mountain Region
1601 Lind Avenue SW
Renton, WA 98055-4056
Phone: 425 227-2132
Fax: 425-227-1320
Email: [email protected]
RIN: 2120-AI23
_______________________________________________________________________



DOT--Federal Motor Carrier Safety Administration (FMCSA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




109. [rplus]UNIFIED REGISTRATION SYSTEM
Priority:


Other Significant


Legal Authority:


PL 104-88; 109 Stat. 803, 888 (1995); 49 USC 13908


CFR Citation:


49 CFR 360, 365, 366, 368, 387, and 390


Legal Deadline:


Final, Statutory, January 1, 1998.


Abstract:


This action proposes replacing three current identification and 
registration systems--USDOT identification number system, registration/
licensing system, and financial responsibility system--with a unified 
registration system. It will consolidate and simplify current Federal 
registration processes and increase public accessibility to data about 
interstate and foreign motor carriers, property brokers, and freight 
forwarders. In addition, the agency invites comments on how it might 
replace a fourth system--single-State registration system--in a manner 
consistent with conditions imposed by statute.


Statement of Need:


As a result of the ICC Termination Act of 1995 [Public Law 104-88, 
December 29, 1995, 109 Stat. 888] (ICCTA), Congress terminated the 
Interstate Commerce Commission and transferred its functions concerning 
licensing and financial responsibility requirements to the DOT. 
Congress mandated that the agency consider unifying the four current 
systems with a single, on-line Federal system.


Summary of Legal Basis:


The ICCTA created a new 49 U.S.C. 13908 directing ``[t]he Secretary, in 
cooperation with the States, and after notice and opportunity for 
public comment,'' . . . to ``issue regulations to replace the current 
DOT identification number system, the single State registration system 
under section 14504, the registration system contained in this chapter, 
and the financial responsibility information system under section 13906 
with a single, on-line, Federal system.''


Alternatives:


FMCSA considered several alternatives to the proposal discussed here, 
in an effort to minimize the potential new filing burden on small 
entities. For instance, we considered exempting existing carriers from 
certain new filing requirements (via a grandfather clause), with the 
idea that it would minimize the compliance costs of this proposal. 
However, while reducing compliance costs (and thereby improving filing 
efficiency), it would also have reduced, not enhanced, the fairness of 
the motor carrier registration process relative to the status quo by 
placing higher burdens on new entrants than existing carriers. As such, 
it would have acted as a barrier to entry to small new entrants to the 
benefit of existing carriers.


Conversely, we also considered exempting new entrants from these 
requirements, but dismissed this on the grounds that it too would have 
reduced the fairness of the registration process. Additionally, either 
option would have reduced safety relative to the proposal discussed 
here. Exempting new entrants from various requirements would not have 
assisted small entities over larger ones, given that the composition of 
the new entrant carrier universe is similar to that of the overall 
existing population (namely, 80 percent have six or fewer power units).


The agency also considered removing the process agent designation 
filing requirement on the grounds that it was the most costly of the 
initiatives in this proposal. However, the agency dismissed this option 
because FMCSA division administrators felt that this particular filing 
requirement had the best potential to increase industry safety by 
improving the productivity of the agency's safety investigators 
(thereby allowing them to initiate additional compliance reviews). 
Additionally, the process agent designation filing requirement also 
enhances the fairness of the agency's registration process.


Anticipated Cost and Benefits:


The regulatory evaluation for the NPRM will be placed in the docket.


Risks:


FMCSA will decide if a risk assessment is necessary.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           61 FR 43816                                    08/26/96

[[Page 72804]]

ANPRM Comment Period End                                       10/25/96
NPRM                                                           02/00/05
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Federal, State


Additional Information:


Docket No. FMCSA-97-2349.


URL For More Information:
dms.dot.gov
URL For Public Comments:
dms.dot.gov
Agency Contact:
Valerie Height
Transportation Specialist
Department of Transportation
Federal Motor Carrier Safety Administration
MC-PRR
Office of Policy Plans and Regulation (MC-PRR)
400 Seventh Street SW.
Washington, DC 20590
Phone: 202 366-0901
RIN: 2126-AA22
_______________________________________________________________________



DOT--FMCSA



110. [rplus]HOURS OF SERVICE OF DRIVERS; SUPPORTING DOCUMENTS
Priority:


Other Significant


Legal Authority:


PL 103-311, sec 113; 108 Stat. 1673, 1676 (1994); 49 USC 504; 49 USC 
14122, 31133, 31136, and 31502


CFR Citation:


49 CFR 385, 390, and 395


Legal Deadline:


Final, Statutory, February 1996.


Abstract:


This rulemaking would amend the hours-of-service recordkeeping 
requirements to clarify what supporting documents motor carriers must 
have to validate hours of service records. It will clarify: That the 
duty of motor carriers is to verify the accuracy of drivers' hours of 
service (HOS) and records of duty status (RODS) if including automatic 
on-board records; that the driver's duty is to collect and submit to 
the motor carrier all supporting documents with the RODS; that carriers 
are required to maintain supporting documents with the RODS; and that a 
supporting document based on a self-monitoring system is required to be 
the primary method for ensuring compliance with the HOS regulations. It 
would allow the use of electronic documents as a supplement to, and in 
certain instances in lieu of, paper supporting documents in recognition 
of developing technologies. It would clarify the definitions of 
``supporting documents,'' ``employee,'' and ``driver,'' and the current 
requirement that each motor carrier use a self-monitoring system to 
verify HOS and RODS.


Statement of Need:


In order for the motor carriers to ensure that drivers are alert and 
not fatigued, carriers must maintain self-monitoring systems that 
compare records of duty status (RODS) to supporting documents. The 
Federal Highway Administration (FHWA) as part of its regulatory 
oversight to assist motor carriers in operating safely decided to adopt 
this practice of maintaining ``RODS supporting documents.'' On November 
26, 1982, FHWA published a final rule which, in part, required motor 
carriers operating in interstate commerce to retain supporting 
documents, along with drivers' RODS, for at least six months from the 
date of receipt (47 FR 53383). 49 CFR 395.8(k). However, FHWA did not 
define the term ``supporting document'' in that final rule.


Summary of Legal Basis:


FMCSA is authorized, by 49 U.S.C. 504(c), to inspect and copy any 
record of a carrier, lessor, or association and to inspect the 
equipment of a carrier, or lessor, or other person controlling, 
controlled by, or under common control with a carrier, as long as these 
actions were made in furtherance of an investigation and regardless of 
whether or not the records were required to be maintained by FMCSA 
regultions or orders.


This rulemaking is required by sec. 113 (Driver's Record of Duty 
Status) of the Hazardous Materials Transportation Authorization Act of 
1994, Pub. L. 103-311, August 26, 1994, 108 Stat. 1673, at 1676. 
Section 113 assumes the existence of FMCSA's more general authority to 
regulate the HOS of commercial motor vehicle drivers and related 
matters. That authority is conferred by the Motor Carrier Act of 1935, 
now codified at 49 U.S.C. 31502(b), and the Motor Carrier Safety Act of 
1984, 49 U.S.C. 31136(a).


More specifically, sec. 113(b)(2) requires specifying the number and 
kind of supporting documents that must be retained by a motor carrier. 
Section 113(b)(3) requires a regulatory provision specifying how long a 
motor carrier must maintain HOS records. Section 113(b)(4) requires a 
provision authorizing motor carriers (individually or in groups), on a 
case-by-case basis, to use ``self-compliance systems'' that ensure 
driver compliance with the HOS rules and allow enforcement officers to 
audit those systems to validate compliance.


Alternatives:


Reducing the length of records retention would reduce costs, but only 
slightly. Short retention periods would restrict the investigator's 
ability to identify patterns that indicate unsafe practices. The SNPRM 
will solicit comments on alternatives the public may want to offer.


Anticipated Cost and Benefits:


The regulatory evaluation for the SNPRM will be placed in the docket.


Risks:


FMCSA will decide if a risk assessment is necessary.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            63 FR 19457                                    04/20/98
NPRM Comment Period End                                        06/19/98
Supplemental NPR69 FR 63997                                    11/03/04
Supplemental NPRM Comment Period End                           01/03/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


Federal


Additional Information:


Docket No. FMCSA-98-3706.


URL For More Information:
dms.dot.gov
URL For Public Comments:
dms.dot.gov

[[Page 72805]]

Agency Contact:
Jerry Fulnecky
Department of Transportation
Federal Motor Carrier Safety Administration
MC-EC
Office of Enforcement and Compliance
400 Seventh Street, SW.
Washington, DC 20590
Phone: 202 366-2096
Related RIN: Split from 2126-AA23
RIN: 2126-AA76
_______________________________________________________________________



DOT--National Highway Traffic Safety Administration (NHTSA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




111. [rplus]TIRE PRESSURE MONITORING SYSTEMS
Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


This action may affect the private sector under PL 104-4.


Legal Authority:


49 USC 322; 49 USC 30111; 49 USC 30115; 49 USC 30117; . . .


CFR Citation:


49 CFR 571.138; 49 CFR 571.101


Legal Deadline:


None


Abstract:


The Transportation Recall Enhancement Accountability and Documentation 
(TREAD) Act required the Secretary of Transportation to initiate 
rulemaking to require a warning system in new motor vehicles to 
indicate to the operator when a tire is significantly under-inflated. 
The agency issued a final rule for tire pressure monitoring systems 
(TPMS)(establishing FMVSS No. 138) on June 5, 2002; however, the final 
rule establishing the standard was vacated by a decision issued by the 
U.S. Court of Appeals for the Second Circuit in August 2003.


The agency will take action in accordance with the Administrative 
Procedures Act to re-establish FMVSS No. 138, in a manner consistent 
with the court's decision, and also provide a new phase-in period.


Statement of Need:


The TPMS rulemaking is one of the rulemakings mandated by the 
Transportation Recall Enhancement Accountability and Documentation Act 
of 2000. To prevent vehicles from being driven on under-inflated tires, 
Congress mandated the installation of tire pressure monitoring systems 
that will warn drivers when one or more tires, up to a total of 4, are 
under-inflated. Under-inflation can lead to over-heating of the tires 
and sudden tire failures (blowouts and tread separations).


Summary of Legal Basis:


49 USC 322, 49 USC 30111, 49 USC 30115, 49 USC 30117, and 49 USC 30166 
provide the legal basis.


Alternatives:


Potential alternatives to the TPMS rulemaking proposed by the agency 
include:


 No rulemaking to require that drivers be warned when a tire(s) 
is significantly under-inflated (NB: this alternative is not permitted 
under the TREAD Act); and


 Variations of the proposed TPMS performance requirements 
(especially the threshold level of under-inflation the triggers a 
warning to the driver) and test procedures.


Anticipated Cost and Benefits:


The agency estimates that the TPMS rule will prevent approximately 120 
fatalities annually, and prevent or reduce in severity approximately 
8,400 injuries. The TPMS rule will also provide economic benefits by 
reducing tire tread wear, improving vehicle fuel economy, and reducing 
property damage when collisions do occur.


The agency estimates the total net cost per vehicle for the TPMS to be 
between $26.00 and $100.00.


Risks:


There is a potential risk that some drivers might rely on TPMS and not 
check the pressure in their tires on a regular basis. To guard against 
that possibility, the agency has proposed requiring vehicle 
manufacturers to include in their vehicle owner's manuals a statement 
emphasizing the need for motorists to check tire pressure monthly, and 
explaining the consequences of not doing so.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            69 FR 55896                                    09/16/04
NPRM Comment Period End                                        11/15/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Federalism:


 This action may have federalism implications as defined in EO 13132.


URL For More Information:
dms.dot.gov
URL For Public Comments:
dms.dot.gov
Agency Contact:
Samuel Daniel
General Engineer Office of Crash Avoidance Stds.
Department of Transportation
National Highway Traffic Safety Administration
NVS-122
400 Seventh Street SW.
Washington, DC 20590
Phone: 202 366-4921
RIN: 2127-AJ23
_______________________________________________________________________



DOT--Federal Railroad Administration (FRA)

                              -----------

                            FINAL RULE STAGE

                              -----------




112. [rplus]WHISTLE BANS AT HIGHWAY-RAIL GRADE CROSSINGS
Priority:


Other Significant


Legal Authority:


49 USC 20153


CFR Citation:


49 CFR 222


Legal Deadline:


Final, Statutory, November 2, 1996, subsequent enactment prohibited 
issuance prior to July 1, 2001.


Abstract:


This action would govern when train whistles at public grade crossings 
must be sounded. FRA has found that failing to use the locomotive horn 
can significantly increase the number of collisions with motorists 
using the crossing. This action is considered significant because of 
substantial public interest. This action is being taken

[[Page 72806]]

pursuant to statutory mandate. Pub. Law 103-440 requires the Secretary 
to prohibit local whistle bans, except where there is no significant 
risk of accidents, alternative safety measures are adequate, or where 
use of a horn as a warning is impractical. After publishing an NPRM, 
FRA participated in extensive public hearings to gather comments and 
issued an interim final rule to implement the statute.


Statement of Need:


This rule is required by Public Law 103-440. The Act requires the use 
of locomotive horns at every public highway-rail grade crossing but 
gives FRA the authority to make reasonable exceptions. Studies have 
shown that highway-rail grade crossing accidents increase 67 percent at 
gated crossings where whistle bans are in effect. Congress amended this 
law in 1996 to require that FRA take into account the interest of the 
communities with pre-existing restrictions on locomotive horns. In 
2000, Congress prohibited FRA from issuing a rule before July 1, 2001.


Summary of Legal Basis:


Issuance of this rule is required by 49 USC 20153.


Alternatives:


There was no alternative to initiating this rulemaking, as it is 
required by statute. However, the rule would provide a list of 
supplementary measures that FRA has determined to be effective 
substitutes for the locomotive horn in the prevention of highway-rail 
grade crossing casualties. The rule would also allow for whistle bans 
if there are alternative safety measures that compensate for the lack 
of a locomotive horn.


Anticipated Cost and Benefits:


The problems considered by this rule are collisions and their 
associated casualties and property damage involving vehicles on public 
highways and trains at whistle-ban grade crossings.


The costs of this rulemaking will be incurred predominantly by 
communities. The most significant impacts from this rule will be on 
about 260 governmental jurisdictions whose communities have whistle 
bans in place. However, there are also costs to railroads and to the 
Federal Government. Approximately 640 small railroads would be 
minimally impacted by train horn sound level testing requirements 
contained in this rule. In adddition, some small businesses that 
operate along or near rail lines that currently have whistle bans in 
place could be moderately impacted.


Risks:


As a result of studies conducted on accident rates at crossings at 
which locomotive horns are banned, FRA has concluded that such 
crossings generally have a higher risk of accident than crossings at 
which horns are sounded. FRA has found that the risk of a collision was 
67 percent greater at crossings equipped with automatic gates and 
flashing lights than at similarly equipped crossings across the nation 
without bans. Congress required that FRA issue a regulation requiring 
the sounding of locomotive horns at all public highway rail grade 
crossings. However, an exception to the requirement is permissible in 
circumstances in which there is not a significant risk of loss of life 
or serious personal injury, use of the locomotive horn is impractical, 
or supplementary safety measures fully compensate for the absence of 
the warning provided by the horn. Issuance of the rule would lower the 
increased collision risk associated with crossings at which no 
locomotive horns are sounded.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            65 FR 2230                                     01/13/00
NPRM Comment Period End                                        05/26/00
Interim Final Ru68 FR 70586                                    12/18/03
Interim Final Rule Comment Period End                          04/19/04
Final Rule                                                     01/00/05
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Federal, Local, State


Additional Information:


An Omnibus Bill at the end of the 106th Congress prohibited publication 
of a final rule before July 2001.


URL For More Information:
dms.dot.gov
URL For Public Comments:
dms.dot.gov
Agency Contact:
Kathryn E. Shelton
Trial Attorney
Department of Transportation
Federal Railroad Administration
400 Seventh Street, SW
Washington, DC 20590
Phone: 202 493-6063
Fax: 202 493-6068
Email: [email protected]
RIN: 2130-AA71
BILLING CODE 4910-62-S

[[Page 72807]]




DEPARTMENT OF THE TREASURY (TREAS)



Statement of Regulatory Priorities
 The primary missions of the Department of the Treasury are:
 To promote prosperous and stable American and world economies, 
            including promoting domestic economic growth and 
            maintaining our Nation's leadership in global economic 
            issues, supervising national banks and thrift institutions, 
            and helping to bring residents of distressed communities 
            into the economic mainstream.
 To manage the Government's finances by protecting the revenue 
            and collecting the correct amount of revenue under the 
            Internal Revenue Code, overseeing customs revenue 
            functions, financing the Federal Government and managing 
            its fiscal operations, and producing our Nation's coins and 
            currency.
 To safeguard our financial systems by enforcing laws relating 
            to Federal Government securities and developing regulations 
            to combat money laundering.
 Consistent with these missions, most regulations of the Department and 
its constituent bureaus are promulgated to interpret and implement the 
laws as enacted by the Congress and signed by the President. Unless 
circumstances require otherwise, it is the policy of the Department to 
issue a notice of proposed rulemaking and carefully consider public 
comments before adopting a final rule. Also, in particular cases, the 
Department invites interested parties to submit views on rulemaking 
projects while a proposed rule is being developed, and holds public 
hearings to discuss proposed rules.
 In response to the events of September 11, 2001, the President signed 
the USA PATRIOT Act of 2001 into law on October 26, 2001. Since then, 
the Department of the Treasury has accorded the highest priority to 
developing and issuing regulations to implement the provisions in this 
historic legislation that target money laundering and terrorist 
financing. These efforts, which will continue during the coming year, 
are reflected in the regulatory priorities of the Financial Crimes 
Enforcement Network (FinCEN).
 On November 26, 2002, the President signed into law the Terrorism Risk 
Insurance Act of 2002. The purpose of this legislation is to address 
disruptions in the market for terrorism risk insurance. The new law 
established a temporary Federal reinsurance program under which the 
Federal Government will share the risk of losses associated with 
certain types of terrorist acts with commercial property and casualty 
insurers. Over the past two years, the Department of the Treasury has 
accorded the highest priority to developing and issuing regulations to 
implement the provisions of this Act. These efforts, which will 
continue during the coming year, are reflected in the regulatory 
priorities of the Terrorism Risk Insurance Program Office.
 To the extent permitted by law, it is the policy of the Department to 
adhere to the regulatory philosophy and principles set forth in 
Executive Order 12866, and to develop regulations that maximize 
aggregate net benefits to society while minimizing the economic and 
paperwork burdens imposed on persons and businesses subject to those 
regulations.
Terrorism Risk Insurance Program Office
 The Office of the Assistant Secretary for Financial Institutions is 
responsible for developing promulgating regulations implementing the 
Terrorism Risk Insurance Act of 2002 (TRIA). The Terrorism Risk 
Insurance Program Office, which is part of the Office of the Assistant 
Secretary for Financial Institutions, is responsible for operational 
implementation of the Act. The purposes of this legislation, which was 
enacted as a consequence of the events of September 11, 2001, are to 
address market disruptions, ensure the continued widespread 
availability and affordability of commercial property and casualty 
insurance for terrorism risk, and to allow for a transition period for 
the private markets to stabilize and build capacity while preserving 
State insurance regulation and consumer protections. TRIA established a 
temporary Federal program that provides a system of shared public and 
private compensation for insured losses resulting from certain types of 
terrorist acts.
 Over the past year, the Office of the Assistant Secretary has 
continued the ongoing work of quickly implementing TRIA. The Office has 
issued formal regulations specifying claims procedures for property and 
casualty insurers who seek federal reimbursement under TRIA for their 
insured losses. The Office has also developed a claims processing 
capability and issued a final rule to implement the litigation 
management provisions of TRIA. During fiscal year 2005, the Office will 
refine regulations and procedures for filing claims under TRIA and 
develop regulations for recouping the Federal share of compensation to 
insurers through risk-spreading premiums.
Customs Revenue Functions
 On November 25, 2002, the President signed the Homeland Security Act 
of 2002 (the Act), establishing the Department of Homeland Security 
(DHS). The Act transferred the United States Customs Service from the 
Department of the Treasury to the DHS, where it is now known as the 
Bureau of Customs and Border Protection (CBP). Notwithstanding the 
transfer of the Customs Service to DHS, the Act provides that the 
Secretary of the Treasury retains sole legal authority over the customs 
revenue functions. The Act also authorizes the Secretary of the 
Treasury to delegate any of the retained authority over customs revenue 
functions to the Secretary of Homeland Security. By Treasury Department 
Order No. 100-16, the Secretary of the Treasury delegated to the 
Secretary of Homeland Security authority to prescribe regulations 
pertaining to the customs revenue functions. This Order further 
provided that the Secretary of the Treasury retained the sole authority 
to approve any such regulations concerning import quotas or trade bans, 
user fees, marking, labeling, copyright and trademark enforcement, and 
the completion of entry or substance of entry summary including duty 
assessment and collection, classification, valuation, application of 
the U.S. Harmonized Schedules, eligibility or requirements for 
preferential trade programs, and the establishment of recordkeeping 
requirements relating thereto.
 During fiscal year 2005, Treasury and CBP plan to finalize several 
interim regulations involving the customs revenue functions not 
delegated to DHS. Among these are the following interim regulations 
that implement the trade benefit provisions of the Trade Act of 2002:
 The Andean Trade Promotion and Drug Eradication Act
 The Caribbean Basin Economic Recovery Act
 The African Growth and Opportunity Act
 CBP also plans to issue interim regulations this fiscal year to 
implement the preferential trade benefit provisions of the United 
States-Chile Free Trade

[[Page 72808]]

Agreement Implementation Act and the United States-Singapore Free Trade 
Agreement Implementation Act.
 In addition, Treasury and CBP plan to finalize proposed regulations 
that will implement two provisions of the Tariff and Suspension Act of 
2000. One rule will establish procedures for allowing the duty-free 
entry of prototypes that are to be used exclusively in product 
development, testing, evaluation or quality control. The other rule 
will allow merchandise that is purchased and invoiced as a single 
entity but shipped in an unassembled or disassembled condition in 
separate shipments due to the size or nature of the merchandise to be 
treated for entry purposes as a single transaction.
 Treasury and CBP also plan to continue moving forward with amendments 
to improve its regulatory procedures began under the authority granted 
by the Customs Modernization provisions of the North American Free 
Trade Implementation Act (Customs Mod Act). These efforts, in 
accordance with the principles of Executive Order 12866, have involved 
and will continue to involve significant input from the importing 
public. CBP will also continue to test new programs to see if they work 
before proceeding with proposed rulemaking to permanently establish the 
programs.
Community Development Financial Institutions Fund
 The Community Development Financial Institutions Fund (Fund) was 
established by the Community Development Banking and Financial 
Institutions Act of 1994 (12 U.S.C. 4701 et seq.). The primary purpose 
of the Fund is to promote economic revitalization and community 
development through a variety of programs: the Community Development 
Financial Institutions (CDFI) Program, the Bank Enterprise Award (BEA) 
Program, and the New Markets Tax Credit (NMTC) Program.
 In fiscal year 2005, the CDFI Program will comprise the Financial 
Assistance Component through which the Fund makes investments in and 
provides financial assistance to CDFIs, and the Technical Assistance 
Component through which the Fund provides technical assistance grants 
to CDFIs. In addition, the Fund administers the Native American CDFI 
Assistance (NACA) Component, through which the Fund provides technical 
assistance grants and financial assistance awards to promote the 
development of CDFIs that serve Native American, Alaska Native, and 
Native Hawaiian communities.
 Through the BEA Program, the Fund provides financial incentives to 
encourage insured depository institutions to engage in eligible 
development activities and to make equity investments in CDFIs.
 In addition, the Fund administers the NMTC Program in coordination 
with Treasury's Office of Tax Policy and the Internal Revenue Service. 
The NMTC Program is intended to spur investments in businesses located 
in low-income communities. Through the NMTC Program, taxpayers are 
provided a credit against Federal income taxes for qualified 
investments made to acquire stock or other equity interests in 
designated Community Development Entities (CDEs). Substantially all of 
the proceeds of qualified investments must in turn be used by the CDE 
to make qualified investments in low-income communities.
 The Fund's fiscal year 2005 regulatory priority will include 
developing guidance and/or regulations regarding aspects of the 
administration and operation of the NMTC Program.
Financial Crimes Enforcement Network
 The regulations of the Financial Crimes Enforcement Network (FinCEN) 
constitute the core of Treasury's anti-money laundering initiatives and 
are an essential component of Treasury's anti-narcotics effort. 
FinCEN's regulations implement the Bank Secrecy Act (BSA), as amended 
in October 2001 by the USA PATRIOT Act. The BSA authorizes the 
Secretary of the Treasury to issue regulations requiring financial 
institutions to keep records and file reports that are determined to 
have a high degree of usefulness in criminal, tax, or regulatory 
matters, or in the conduct of intelligence or counter-intelligence 
activities to protect against international terrorism, and to implement 
counter-money laundering programs and compliance procedures. FinCEN is 
working closely with the Treasury Offices of the General Counsel, 
Terrorism/Violent Crimes, and Financial Institutions to develop 
regulations to implement the amendments to the BSA made by the USA 
PATRIOT Act that target money laundering and terrorist financing.
 FinCEN's regulatory priorities for fiscal year 2005 include the 
following projects, all of which are related to the events of September 
11, 2001:
 Due Diligence for Correspondent Accounts and Private 
            Banking Accounts. This final rule implements section 312 of 
            the USA PATRIOT Act, which requires certain financial 
            institutions to establish due diligence policies, 
            procedures, and controls reasonably designed to detect and 
            report money laundering through correspondent accounts and 
            private baking accounts established or maintained for non-
            U.S. persons.
 Anti-Money Laundering Programs. These final and 
            proposed rules implement section 352 of the USA PATRIOT 
            Act, under which financial institutions must adopt anti-
            money laundering programs. FinCEN expects to finalize 
            interim final rules issued in April 2002 for banks and 
            other depository institutions, casinos, securities broker-
            dealers, futures commission merchants, mutual funds, 
            operators of credit card systems, and money services 
            businesses. FinCEN also expects to finalize rules proposed 
            in September 2002 for insurance companies and unregistered 
            investment companies, rules proposed in February 2003 for 
            dealers in precious metals, stones, or jewels, and rules 
            proposed in May 2003 for investment advisers and commodity 
            trading advisers. FinCEN will issue a proposed rule for 
            loan or finance companies (including pawnbrokers). Finally, 
            FinCEN expects to determine whether to issue a series of 
            proposed rules for other financial institutions--vehicles 
            sellers; persons involved in real estate closings and 
            settlements; and travel agencies--after reviewing comments 
            received in response to a series of advance notices of 
            proposed rulemaking.
 Suspicious Activity Reporting. FinCEN expects to 
            finalize several rules proposed under 31 U.S.C. 5318(g) 
            requiring insurance companies and mutual funds to report 
            suspicious transactions.
Internal Revenue Service
 The Internal Revenue Service, working with the Office of the Assistant 
Secretary (Tax Policy), promulgates regulations that interpret and 
implement the Internal Revenue Code and related tax statutes. The 
purpose of these regulations is to carry out the tax policy determined 
by Congress in a fair, impartial and reasonable manner, taking into 
account the intent of Congress, the realities of relevant transactions, 
the need for the Government to administer the rules and monitor 
compliance, and the overall integrity of the Federal tax system. The 
goal is to make the

[[Page 72809]]

regulations practical and as clear and simple as possible.
 Most Internal Revenue Service regulations interpret tax statutes to 
resolve ambiguities or fill gaps in the tax statutes. This includes 
interpreting particular words, applying rules to broad classes of 
circumstances, and resolving apparent and potential conflicts between 
various statutory provisions.
 During fiscal year 2005 the Internal Revenue Service will accord 
priority to the following regulatory projects:
 Transfer Pricing Guidance Initiatives. Treasury and 
            the IRS anticipate issuing regulatory guidance under 
            section 482 and other provisions of the Internal Revenue 
            Code during fiscal year 2005 with respect to accounting for 
            the economic value of intangible property in the context of 
            cross-border related-party activities and transactions. The 
            economic value of intangible property can be a significant 
            factor in a variety of cross-border transactions, in 
            addition to those in which intangibles are sold or licensed 
            directly. The various guidance projects are being 
            coordinated to ensure that consistent rules govern the 
            treatment of intangibles in economically similar 
            transactions, whether intangibles are transferred outright, 
            transferred via a buy-in pursuant to a cost sharing 
            arrangement, embedded into services performed, or 
            transferred as part of an outbound incorporation or 
            reorganization transfer. The projects include regulatory 
            guidance regarding related-party cost sharing arrangements 
            under section 482, regarding intercompany services under 
            section 482, and regarding outbound transfers of 
            intangibles in a reorganization under section 367(d).
 Elimination or Reduction of Certain Type of Benefits 
            in Qualified Plans. Section 411(d)(6)(B) of the Internal 
            Revenue Code generally prohibits an amendment to a tax-
            qualified retirement plan that has the effect of 
            eliminating or reducing an early retirement benefit or a 
            retirement-type subsidy, or eliminating an optional form of 
            benefit, with respect to benefits attributable to service 
            before the amendment. EGTRRA directed the Secretary to 
            issue regulations providing that section 411(d)(6)(B) does 
            not apply to any amendment that reduces or eliminates early 
            retirement benefits or retirement-type subsidies that 
            create significant burdens or complexities for the plan and 
            plan participants unless such amendment adversely affects 
            the rights of any participant in a more than de minimis 
            manner. The IRS and Treasury issued proposed regulations 
            that would implement this provision and provide additional 
            guidance under section 411(d)(6) on March 24, 2004. The IRS 
            and Treasury intend to finalize these regulations.
 Application of the Repeal of the General Utilities 
            Doctrine in the Context of Consolidated Returns. On March 
            7, 2002, the IRS and Treasury issued temporary regulations 
            (26 CFR 1.337(d)-2T) that disallow certain losses 
            recognized by a member of a consolidated group on the 
            disposition of stock of another member. These regulations 
            ensure that the purposes of the General Utilities repeal, 
            which generally requires a corporation to recognize gain or 
            loss on a disposition of any asset, may not be circumvented 
            through the use of the consolidated return regulations. 
            During the coming fiscal year, the IRS and Treasury plan to 
            reexamine these regulations.
 Safe Harbor Methodology for Determining the Fair 
            Market Value of Financial Instruments that are Marked to 
            Market. Section 475 of the Internal Revenue Code requires 
            dealers in stocks, debt, certain derivative financial 
            instruments, or other securities to mark their securities 
            to market at the end of each tax year. That is, those 
            dealers must compute their taxable income by including 
            their securities in inventory at their fair market value or 
            recognizing gain or loss as if their securities had been 
            sold for their fair market value at the end of the tax 
            year. Dealers and traders in commodities, and securities 
            traders are not required to use mark-to-market accounting 
            but may elect to do so. The IRS and Treasury are 
            considering whether to publish proposed regulations that 
            would allow dealers in securities (and perhaps dealers in 
            commodities or traders in securities or commodities) to use 
            a safe harbor method to satisfy the statutory requirement 
            to determine the fair market value of items marked to 
            market. As a first step in this process, the IRS and 
            Treasury issued an advance notice of proposed rulemaking 
            (ANPRM) on May 5, 2003, describing and explaining a 
            possible framework for a safe harbor that might allow 
            taxpayers to use as fair market value for section 475 
            purposes the value used on certain financial statements. 
            That ANPRM stated certain broad principles that any safe 
            harbor finally adopted might have to meet. The ANPRM also 
            requested both general and specific comments concerning the 
            adoption of a safe harbor based on financial statement 
            conformity or some other principle. It also requested 
            comments concerning the scope of any safe harbor, which 
            taxpayers could use it, what financial statements would 
            qualify, and what securities (or commodities) would be 
            covered.
 Capitalization of Interest and Carrying Charges 
            Properly Allocable to Straddles. Sections 1092 and 263(g) 
            of the Internal Revenue Code were enacted in 1981 to 
            address tax abuses employing straddles in commodity futures 
            contracts, but the two sections are worded broadly enough 
            to deal with other abusive straddles. Section 1092 limits 
            loss recognition on one leg of a straddle if there is 
            unrecognized gain with respect to one or more offsetting 
            positions. Section 263(g) disallows a deduction for 
            interest and carrying charges properly allocable to 
            personal property that is part of a straddle.
 The IRS and Treasury expect to issue final regulations clarifying the 
circumstances in which a taxpayer must capitalize interest and carrying 
charges incurred to purchase or carry personal property that is part of 
a straddle. The regulations are expected to address the definition of 
personal property for purposes of section 263(g), the types of expenses 
subject to capitalization, and the operation of the capitalization 
rules. In addition, the regulations will indicate when the debtor's 
position in a debt instrument will be treated as a position in personal 
property that may be part of a straddle. The regulations are also 
expected to clarify the application of the straddle anti-abuse rules to 
various financial instruments and straddle transactions.
 Credit for Household and Dependent Care Services. 
            Section 21 of the Internal Revenue Code allows a credit for 
            an amount equal to a percentage of employment-related 
            expenses paid by an individual who maintains a household 
            that includes a qualifying individual (usually a child 
            under age 13). Section 21, originally enacted in 1976, has 
            been amended repeatedly. The 2001 amendments increased the 
            credit significantly. The regulations, currently found 
            under section 1.44A of the Income Tax Regulations, have not 
            been amended or updated since 1984. This regulation project 
            will update the regulations to reflect the

[[Page 72810]]

            statutory changes and will clarify issues relating to 
            payments for certain services.
 Deduction and Capitalization of Costs for Tangible 
            Assets. Section 162 of the Internal Revenue Code allows a 
            current deduction for ordinary and necessary expenses paid 
            or incurred in carrying on any trade or business. Under 
            section 263(a), no immediate deduction is allowed for 
            amounts paid out for new buildings or for permanent 
            improvements or betterments made to increase the value of 
            any property or estate. Such expenditures are capital 
            expenditures that generally may be recovered only in future 
            taxable years, as the property is used in the taxpayer's 
            trade or business. It often is not clear whether an 
            expenditure to repair, improve, or rehabilitate property is 
            a deductible expense or is a capital expenditure. Although 
            existing regulations provide that a deductible repair is an 
            expenditure that does not materially add to the value of 
            the property nor appreciably prolong its life, the IRS and 
            Treasury believe that additional clarification is needed to 
            reduce uncertainty and controversy in this area. In 
            December 2003, the IRS and Treasury requested public 
            comment on rules that might be provided to clarify the 
            application of section 263(a) to repairs and improvements 
            to tangible property. During fiscal year 2005, the IRS and 
            Treasury intend to propose regulations in this area.
 R&E Credit for Controlled Groups. Section 41 of the 
            Internal Revenue Code provides a credit for increasing 
            research expenditures. The R&E Credit has been the subject 
            of significant controversy between the IRS and taxpayers, 
            particularly as it relates to the computation and 
            allocation of the credit for members of a controlled group 
            of corporations or a group of trades or businesses under 
            common control. Section 41(f) generally provides that in 
            determining the amount of the credit, all members of the 
            same controlled group of corporations are treated as a 
            single taxpayer. The IRS and Treasury issued proposed 
            regulations in 2003 providing rules for the computation of 
            the group research credit, and allocation of that credit 
            among members of the controlled group. During fiscal year 
            2005, the IRS and Treasury intend to issue further guidance 
            on this issue.
 Partnership Equity for Services. Like other 
            businesses, partnerships frequently issue interests in 
            partnership equity to service providers. Although there 
            currently is some guidance on a partnership's issuance of a 
            profits interest to a service provider, there is little 
            guidance on the Federal income tax consequences (to the 
            service provider and the partnership) on the issuance, in 
            connection with the performance of services, of an interest 
            in partnership capital or an option to acquire such an 
            interest. More specifically, uncertainty exists as to 
            whether the principles of section 83 of the Internal 
            Revenue Code apply to the issuance of such interests and 
            whether the partnership recognizes gain on the issuance of 
            a capital interest to, or the exercise of an option by, a 
            service provider. In this project, the IRS and Treasury 
            will provide guidance on these and related issues.
 Corporate Estimated Tax. Section 6655 of the 
            Internal Revenue Code sets forth the requirements for the 
            payment of estimated income taxes by corporations. The 
            existing regulations under section 6655 do not reflect 
            significant changes to the tax law since 1984. The IRS and 
            Treasury expect to issue proposed regulations that will 
            reflect changes to the tax law since 1984 and that will 
            provide clear rules for taxpayers to follow and the IRS to 
            administer. Among other issues, the proposed regulations 
            will address the alternative methods for computing 
            quarterly installments of estimated tax and the treatment 
            of certain items when computing quarterly installments of 
            estimated tax.
 Practice Before the Internal Revenue Service 
            (Circular 230). Section 330 of title 31 of the United 
            States Code authorizes the Secretary of the Treasury to 
            regulate the practice of representatives before the 
            Treasury Department. The Secretary has published these 
            regulations in Circular 230 (31 CFR part 10). In 2001, the 
            IRS and Treasury issued proposed amendments to the 
            regulations relating to practice before the IRS, which 
            addressed general matters and proposed standards of 
            practice for tax shelter opinions. In 2002, final 
            regulations were issued incorporating only the non-tax 
            shelter matters. In 2003, amendments to the standards of 
            practice for tax shelter opinions were reproposed. Those 
            reproposed regulations set forth best practices for tax 
            advisors providing advice to taxpayers relating to Federal 
            tax issues or submissions to the IRS and modified the 
            standards for certain tax shelter opinions. The IRS and 
            Treasury expect to finalize the reproposed regulations and 
            to issue additional regulations regarding practice before 
            the IRS.
 Student FICA Exception. Section 3121(b)(10) of the 
            Internal Revenue Code provides that for purposes of the 
            FICA, employment does not include services performed for a 
            school, college or university by a student who is enrolled 
            and regularly attending classes at the institution. Thus, 
            compensation for services that come within this exception 
            is not subject to FICA tax. As a result of some recent 
            litigation, questions have arisen as to the scope of the 
            exception. In particular, there is a need for additional 
            guidance on who is a student and what constitutes a school, 
            college or university for purposes of this exception. The 
            IRS and Treasury issued proposed regulations that would 
            clarify the application of section 3121(b)(10) on February 
            25, 2004. The IRS and Treasury intend to finalize these 
            regulations.
Office of the Comptroller of the Currency
 The Office of the Comptroller of the Currency (OCC) charters, 
regulates, and supervises national banks to ensure a safe, sound, and 
competitive national banking system that supports the citizens, 
communities, and economy of the United States. The substantive content 
of the OCC's regulations reflects four organizing principles that 
support this mission:
 The OCC's regulations help ensure safety and soundness by 
            establishing standards that set the limits of acceptable 
            conduct for national banks.
 The OCC's regulations promote competitiveness by facilitating 
            a national bank's ability to develop new lines of business, 
            subject to any safeguards that are necessary to ensure that 
            the bank has the expertise to manage risk effectively and 
            adapt its business practices to deal responsibly with its 
            customers.
 Regulations can also affect national banks' ability to compete 
            by contributing significantly to their costs. The OCC's 
            goal is to improve efficiency and reduce burden by updating 
            and streamlining its regulations and eliminating those that 
            no longer contribute significantly to the fulfillment of 
            its mission.
 The OCC's regulations help assure fair access to financial 
            services for all Americans by removing unnecessary

[[Page 72811]]

            impediments to the flow of credit to consumers and small 
            businesses, by encouraging national banks' involvement in 
            community development activities, and by implementing 
            Federal laws designed to protect consumers of financial 
            services.
 The OCC's regulatory workload and plans are affected directly by 
statute. One statute requiring regulatory action is the Economic Growth 
and Regulatory Paperwork Reduction Act of 1996 (EGRPRA). The OCC, 
together with the Board of Governors of the Federal Reserve System, 
Federal Deposit Insurance Corporation, and the Office of Thrift 
Supervision (agencies), is conducting a review of its regulations, 
pursuant to the EGRPRA. This process will continue through 2006. To 
date, the agencies' review has included: (1) issuing three notices, 
published in the Federal Register, that solicit comment from the 
industries we regulate and the public on ways to reduce regulatory 
burden with respect to specific categories of regulations; and (2) 
conducting outreach meetings with bankers and consumer groups in cities 
across the country for the same purpose. The review process and 
outreach meetings have generated a number of helpful suggestions which 
we, along with the other agencies, are evaluating on an ongoing basis. 
When these processes for obtaining input are complete, the OCC expects 
to be able to determine whether revisions to any of its rules are 
appropriate in order to further the purposes of the EGRPRA and reduce 
burden. The agencies will further report to Congress on their 
conclusions at the end of the process, along with any suggestions for 
possible legislative changes.
 Significant final rules issued during fiscal year 2004 include:
 Rules, Policies, and Procedures for Corporate 
            Activities; Bank Activities and Operations; Real Estate 
            Lending and Appraisals (12 CFR Parts 3, 5, 6, 7, 9, 28, and 
            34). The Office of the Comptroller of the Currency issued 
            this rule revising 12 CFR parts 5 and 7 to implement new 
            authority provided to national banks by sections 1204, 
            1205, and 1206 of the American Homeownership and Economic 
            Opportunity Act of 2000. Section 1204 permits national 
            banks to reorganize directly to be controlled by a holding 
            company. Section 1205 increases the maximum term of service 
            for national bank directors, permits the OCC to adopt 
            regulations allowing for staggered terms for directors, and 
            permits national banks to apply for permission to have more 
            than 25 directors. Section 1206 permits national banks to 
            merge with one or more of their nonbank affiliates, subject 
            to OCC approval. The OCC also made other amendments to 12 
            CFR parts 5, 7, 9, and 34, as well as several technical 
            corrections. The OCC published a final rule on December 17, 
            2003, at 68 FR 70122.
 Rules, Policies, and Procedures for Corporate 
            Activities; International Banking Activities (12 CFR Parts 
            5 and 28). The Office of the Comptroller of the Currency 
            issued this rule to amend its regulations pertaining to the 
            foreign operations of national banks, and of Federal 
            branches and agencies of foreign banks operating in the 
            United States. The OCC clarified and revised a number of 
            application procedures, including applicable standards for 
            approval. The rule permits Federal branches and agencies to 
            operate with one license in the United States, with a 
            license issued only for the initial Federal branch or 
            agency, rather than requiring each office of a foreign bank 
            to have a separate license. It also permits a Federal 
            branch to operate a loan production office as part of its 
            branch license. In addition, the OCC implemented, through 
            this regulation, a number of OCC interpretations regarding 
            the capital equivalency deposit required of Federal 
            branches and agencies. The OCC also revised several 
            definitions. The OCC published a final rule on December 19, 
            2003, at 68 FR 70691.
 Rules, Policies, and Procedures for Corporate 
            Activities (12 CFR Part 5). The Office of the Comptroller 
            of the Currency issued this rule to require a national bank 
            to receive OCC approval before changing the composition of 
            all, or substantially all, of its assets (1) through sales 
            or other dispositions, or (2) after having sold or disposed 
            of all, or substantially all, of its assets through 
            subsequent purchase, other acquisitions, or other expansion 
            of its operations. The rule provides that, in the second 
            case, the OCC will apply the same standards as it applies 
            to the establishment of a de novo bank. The OCC published a 
            final rule on August 16, 2004, at 69 FR 50293.
 Reporting and Disclosure Requirements for National 
            Banks With Securities Registered Under the Securities 
            Exchange Act of 1934; Securities Offering Disclosure Rules 
            (12 CFR Parts 11 and 16). The Office of the Comptroller of 
            the Currency issued this rule to revise its regulations to 
            reflect amendments to the Securities Exchange Act of 1934 
            (Exchange Act) made by the Sarbanes-Oxley Act of 2002 
            (Sarbanes-Oxley Act). These amendments to the Exchange Act 
            give the OCC the authority to administer and enforce a 
            number of the Sarbanes-Oxley Act's new reporting, 
            disclosure, and corporate governance requirements with 
            respect to national banks that have a class of securities 
            registered under the Exchange Act. The OCC also made 
            conforming revisions to its rules that prescribe securities 
            offering disclosure rules for national banks that issue 
            securities that are not subject to the registration 
            requirements of the Securities Act of 1933. The OCC 
            published a final rule on December 9, 2003, at 68 FR 68489.
 Bank Activities and Operations; Real Estate Lending 
            and Appraisals (12 CFR Parts 7 and 34). The Office of the 
            Comptroller of the Currency issued this rule to add 
            provisions to OCC regulations expressly addressing the 
            applicability of certain types of state laws to national 
            banks' deposit-taking and lending activities. In new 12 CFR 
            7.4007 (pertaining to deposit-taking) and 12 CFR 7.4008 
            (pertaining to non-real estate lending), and in revised 12 
            CFR 34.4 (pertaining to real estate lending), are listed 
            particular types of state laws that are preempted by the 
            rule. Each of these three sections also contains a list of 
            types of state laws that generally are not preempted. In 
            addition, in new 12 CFR 7.4007, 7.4008, and 7.4009 
            (pertaining to other Federally authorized activities), and 
            in revised 12 CFR 34.4, the rule contains s general 
            statement that state laws do not apply to national banks if 
            they ``obstruct, impair, or condition'' the bank's ability 
            to fully exercise its Federally authorized powers.
 The rule operates to preempt, without the need for further analysis, 
only those types of State laws that are listed in 12 CFR 7.4007, 
7.4008, and 34.4. These are State laws for which substantial precedent 
existed, prior to adoption of the preemption rule, recognizing the 
interference they pose to the ability of Federally chartered 
institutions to operate under uniform Federal standards. Thus, the rule 
preempts State laws that impermissibly affect national bank deposit 
taking and lending powers and that are listed in the regulation.

[[Page 72812]]

 Other types of State laws--those not listed in the regulation--remain 
subject to case-by-case evaluation under the longstanding preemption 
standards that the U.S. Supreme Court has established. The rule also 
prohibits a national bank from making any consumer loan based 
predominately on the bank's realization of the foreclosure value of the 
borrower's collateral, without regard to the borrower's ability to 
repay the loan according to its terms. The OCC published a final rule 
on January 13, 2004, at 69 FR 1904.
 Risk-Based Capital Guidelines; Capital Adequacy 
            Guidelines; Capital Maintenance: Interim Capital Treatment 
            of Consolidated Asset-Backed Commercial Paper Program 
            Assets (12 CFR Part 3). The Office of the Comptroller of 
            the Currency, together with the Board of Governors of the 
            Federal Reserve System, Federal Deposit Insurance 
            Corporation, and Office of Thrift Supervision (banking 
            agencies), issued an interim rule with request for comment 
            on October 1, 2003, at 68 FR 56530. The interim rule 
            amended the banking agencies' risk-based capital standards 
            by providing an interim treatment for assets in asset-
            backed commercial paper (ABCP) programs that are 
            consolidated onto the balance sheets of sponsoring banks, 
            bank holding companies, and thrifts (collectively, 
            sponsoring banking organizations) as a result of a recently 
            issued accounting interpretation, Financial Accounting 
            Standards Board Interpretation No. 46, Consolidation of 
            Variable Interest Entities (FIN 46). Specifically, the 
            interim capital treatment allows sponsoring banking 
            organizations to remove consolidated ABCP program assets 
            from their risk-weighted asset base for the purpose of 
            calculating their risk-based capital ratios. The interim 
            rule was issued in conjunction with a joint agency notice 
            of proposed rulemaking that would also require sponsoring 
            banking organizations to hold risk-based capital against 
            liquidity facilities provided to ABCP programs with an 
            original maturity of one year or less, and a risk-based 
            capital charge for early amortization risk associated with 
            certain types of revolving securitizations. The agencies 
            issued a final rule covering both documents on July 28, 
            2004, at 69 FR 44908.
 Bank Activities and Operations (12 CFR Part 7). The 
            Office of the Comptroller of the Currency issued this rule 
            to clarify the scope of its visitorial powers regulation at 
            12 CFR 7.4000. The rule identifies the scope of the 
            activities of national banks for which the OCC's visitorial 
            powers are exclusive under 12 U.S.C. 484, that is, the 
            content and conduct of activities authorized for national 
            banks under Federal law. The rule also clarifies that the 
            ``vested in the courts of justice'' exception in 12 U.S.C. 
            484 pertains to the powers inherent in the judiciary and 
            does not grant to state or other authorities any new right 
            to exercise visitorial powers with respect to national 
            banks. The OCC published a final rule on January 13, 2004, 
            at 69 FR 1895.
 The OCC's regulatory priorities for fiscal year 2005 include projects 
in the following areas:
 The OCC plans to issue rules implementing the requirements of the Fair 
and Accurate Credit Transactions Act of 2003 as follows:
 Proper Disposal of Consumer Information (12 CFR 
            Parts 30 and 41). The Office of the Comptroller of the 
            Currency, Board of Governors of the Federal Reserve System, 
            Federal Deposit Insurance Corporation, and Office of Thrift 
            Supervision (banking agencies) are planning to issue a 
            joint rule to implement section 216 of the Fair and 
            Accurate Credit Transactions Act of 2003. Section 216 
            requires the banking agencies, the National Credit Union 
            Administration, the Securities and Exchange Commission, and 
            the Federal Trade Commission to adopt consistent and 
            comparable regulations, to the extent possible, requiring 
            entities subject to their jurisdiction to properly dispose 
            of consumer information as a means to reduce the risk of 
            identity theft. The agencies issued a joint notice of 
            proposed rulemaking on June 8, 2004, at 69 FR 31913.
 Fair Credit Reporting Regulations; Use of Medical 
            Information (12 CFR Part 41). The Office of the Comptroller 
            of the Currency, Board of Governors of the Federal Reserve 
            System, Federal Deposit Insurance Corporation, Office of 
            Thrift Supervision, and National Credit Union 
            Administration (agencies) are planning to issue a joint 
            rule to implement section 411 of the Fair and Accurate 
            Credit Transactions Act of 2003. Section 411(a) requires 
            the agencies to prescribe regulations that permit creditors 
            to obtain or use medical information for certain credit 
            eligibility purposes. Additionally, section 411(b) 
            authorizes the agencies to issue rules to allow additional 
            sharing of information determined by the agencies to be 
            appropriate or necessary. The agencies issued a joint 
            notice of proposed rulemaking on April 28, 2004, at 69 FR 
            23380.
 Identity Theft Detection, Prevention, and Mitigation 
            Program for Financial Institutions and Creditors (12 CFR 
            Parts 30 and 41). The Office of the Comptroller of the 
            Currency, Board of Governors of the Federal Reserve System, 
            Federal Deposit Insurance Corporation, Office of Thrift 
            Supervision, and National Credit Union Administration, and 
            Federal Trade Commission (agencies) are planning to issue a 
            rule to establish guidelines and regulations to implement 
            section 114 of the Fair and Accurate Credit Transactions 
            Act of 2003. Section 114 requires the agencies to issue 
            jointly guidelines for financial institutions and creditors 
            identifying patterns, practices, and specific forms of 
            activity that indicates the possible existence of identity 
            theft. In addition, the agencies must issue regulations 
            requiring each financial institution and creditor to 
            establish reasonable policies and procedures to implement 
            the guidelines. The regulations must contain a provision 
            requiring a card issuer to notify the cardholder if the 
            card issuer receives a notice of change of address for an 
            existing account, and a short time later receives a request 
            for an additional or replacement card.
 Fair Credit; Affiliate Marketing Regulations (12 CFR 
            Part 41). The Office of the Comptroller of the Currency, 
            Board of Governors of the Federal Reserve System, Federal 
            Deposit Insurance Corporation, Office of Thrift 
            Supervision, and National Credit Union Administration 
            (agencies) are planning to issue a rule to implement the 
            affiliate-sharing provisions of section 214 of the Fair and 
            Accurate Credit Transactions Act of 2003 (FACT Act). The 
            rule would implement the consumer notice and opt-out 
            provisions of the FACT Act regarding the sharing of 
            consumer information among affiliates for marketing 
            purposes. The agencies issued a notice of proposed 
            rulemaking on July 15, 2004, at 69 FR 42502.
The OCC plans to issue other rules as follows:
 Recordkeeping Requirements for Bank Exceptions from 
            Securities Broker or Dealer Registration (12 CFR To Be 
            Determined). The Office of the Comptroller of the Currency, 
            Board of

[[Page 72813]]

            Governors of the Federal Reserve System, Federal Deposit 
            Insurance Corporation, and Office of Thrift Supervision may 
            issue a notice of proposed rulemaking (NPRM) that contains 
            recordkeeping requirements that implement section 204 of 
            the Gramm-Leach-Bliley Act (GLBA). Section 204 directs the 
            Federal banking agencies to establish recordkeeping 
            requirements for banks relying on exceptions to the 
            definitions of ``broker'' and ``dealer'' contained in 
            paragraphs (4) and (5) of section 3(a) of the Securities 
            Exchange Act of 1934. Issuance of this NPRM is contingent 
            on the completion of the Securities and Exchange 
            Commission's rulemaking to implement the substantive 
            provisions of the GLBA.
 Community Reinvestment Act Regulation (12 CFR 25). 
            The Office of the Comptroller of the Currency plans to 
            issue a notice of proposed rulemaking that would revise 
            certain provisions of our rules implementing the Community 
            Reinvestment Act (CRA). The OCC plans to take this action 
            in response to public comments we received on our February 
            2004 CRA proposal (69 FR 5729). The proposal would address 
            regulatory burden imposed on smaller national banks by 
            revising the eligibility requirements for CRA evaluation 
            under the lending, investment, and service tests. 
            Specifically, the proposal would provide a simplified 
            lending test and a flexible and streamlined community 
            development test for small banks with an asset size between 
            $250 million and $1 billion. Holding company affiliation 
            would not be a factor in determining which CRA evaluation 
            standards applied to a bank. The OCC estimates that this 
            proposal would reduce burden and costs for national banks. 
            In particular, banks with assets between $250 million and 
            $1 billion would have reduced data reporting costs that 
            include fixed costs (such as purchasing and updating CRA 
            software and establishing and maintaining internal 
            processes to collect and check data) and variable costs 
            (e.g., organizing data, monitoring data quality, and 
            correcting data).
 Electronic Filing and Disclosure of Beneficial 
            Ownership Reports (12 CFR Part 11). The Office of the 
            Comptroller of the Currency plans to adopt a final rule 
            based on the interim rule, issued on September 22, 2003 , 
            at 68 FR 54981, to implement provisions enacted in the 
            Sarbanes-Oxley Act of 2002 (Act). The Act made amendments 
            to section 16(a) of the Securities Exchange Act of 1934, 
            which requires the filing of beneficial ownership reports 
            by officers, directors, and principal shareholders of 
            issuers of securities. The OCC administers and enforces 
            section 16(a) with respect to officers, directors, and 
            principal shareholders of national banks. Effective July 
            30, 2003, the Act required that beneficial ownership 
            reports be filed electronically and posted on the issuer's 
            corporate Web site, if it has a Web site. The interim rule 
            requires that beneficial ownership reports filed by 
            officers, directors, and principal shareholders of national 
            banks be filed electronically pursuant to the FDIConnect 
            system and that the reports be placed on the Web site on 
            national banks that have Web sites. The OCC may adopt a 
            final rule.
 Risk-Based Capital Guidelines: Implementation of New 
            Basel Capital Accord (12 CFR Part 3). The Office of the 
            Comptroller of the Currency, Board of Governors of the 
            Federal Reserve System, Federal Deposit Insurance 
            Corporation, and Office of Thrift Supervision (banking 
            agencies) plan to issue a notice of proposed rulemaking 
            based on the International Convergence of Capital 
            Measurement and Capital Standards: A Revised Framework, the 
            new capital adequacy framework commonly known as Basel II. 
            The banking agencies published an advance notice of 
            proposed rulemaking (ANPRM) on August 4, 2003, at 68 FR 
            45900 soliciting industry comments on a draft of the 
            proposed framework for implementing the New Basel Capital 
            Accord in the United States. In particular, the ANPRM 
            described significant elements of the Advanced Internal 
            Ratings-Based approach for credit risk and the Advanced 
            Measurement Approaches for operational risk (together, the 
            advanced approaches). The ANPRM specified criteria that a 
            banking organization must meet to use the advanced 
            approaches. Under the advanced approaches, a banking 
            organization would use internal estimates of certain risk 
            components as key inputs in the determination of their 
            regulatory capital requirements. The OCC included this 
            rulemaking project in part II of The Regulatory Plan.
 Safety and Soundness Standards; Interagency Guidance 
            on Response Programs for Unauthorized Access to Customer 
            Information and Customer Notice (12 CFR Part 30). The 
            Office of the Comptroller of the Currency, Board of 
            Governors of the Federal Reserve System, Federal Deposit 
            Insurance Corporation, Office of Thrift Supervision, and 
            National Credit Union Administration (agencies) are issuing 
            an interpretation of section 501(b) of the Gramm-Leach-
            Bliley Act and the Interagency Guidelines Establishing 
            Standards for Safeguarding Customer Information. This 
            interpretation describes the agencies' expectations 
            regarding the response programs, including customer 
            notification procedures, that a financial institution 
            should develop and implement to address the unauthorized 
            access to or use of customer information that could result 
            in substantial harm or inconvenience to a customer. A 
            proposed interpretation was published for comment on August 
            12, 2003, at 68 FR 47954.
Office of Thrift Supervision
 As the primary Federal regulator of the thrift industry, the Office of 
Thrift Supervision (OTS) has established regulatory objectives and 
priorities to supervise thrift institutions effectively and 
efficiently. These objectives include maintaining and enhancing the 
safety and soundness of the thrift industry; a flexible, responsive 
regulatory structure that enables savings associations to provide 
credit and other financial services to their communities, particularly 
housing mortgage credit; and a risk-focused, timely approach to 
supervision.
 OTS and the Office of the Comptroller of the Currency, the Board of 
Governors of the Federal Reserve System, and the Federal Deposit 
Insurance Corporation (collectively, the banking agencies) continue to 
work together on regulations where the agencies share the 
responsibility to implement statutory requirements. The agencies are 
working to update capital standards to maintain, and, where necessary, 
improve consistency in the agencies' rules, including the International 
Convergence of Capital Management and Capital Standards: A Revised 
Framework (Basel II). The domestic implementation of the New Basel 
Capital Accord was introduced in 2003 with publication of an advanced 
notice of proposed rulemaking and draft supervisory guidance. It 
included an introduction to the advanced internal ratings-based (IRB) 
approach to credit risk, and included modifications to the current

[[Page 72814]]

U.S. domestic capital framework. The agencies plan to issue a proposed 
rule by mid-year. Possible changes to capital regulations for U.S. 
institutions not subject to the framework-based regulations will be 
considered and addressed in this same general time frame.
 Also, OTS anticipates implementing sections of the Fair and Accurate 
Credit Transactions Act of 2003 (FACT Act) as follows:
 Proper Disposal of Consumer Information. The banking 
            agencies, along with the National Credit Union 
            Administration (NCUA), the Securities and Exchange 
            Commission (SEC), and the Federal Trade Commission (FTC), 
            plan to issue a final rule implementing section 216 of the 
            FACT Act by amending the Interagency Guidelines 
            Establishing Standards for Safeguarding Customer 
            Information to require each financial institution to 
            develop, implement, and maintain appropriate measures to 
            properly dispose of consumer information derived from 
            consumer reports and to address the risks associated with 
            identity theft as part of its information security program.
 Fair Credit Reporting Affiliate Marketing 
            Regulations. The banking agencies and the NCUA also plan to 
            issue a final rule implementing section 214 of the FACT 
            Act, which amended the Fair Credit Reporting Act (FCRA) by 
            prohibiting a person from using information received from 
            an affiliate to make a solicitation for marketing purposes 
            to a consumer, unless the consumer is given notice and an 
            opportunity and simple method to opt out of the making of 
            such solicitations.
 Fair Credit Reporting Regulations (Medical 
            Information): The banking agencies and the NCUA also plan 
            to publish a final rule implementing section 411 of the 
            FACT Act, which amended the FCRA by (1) prohibiting 
            creditors from obtaining or using medical information 
            pertaining to a consumer in connection with any 
            determination of the consumer's eligibility or continued 
            eligibility for credit, and (2) creating limited exceptions 
            to permit affiliates to share medical information with each 
            other without becoming consumer reporting agencies.
 Identity Theft Detection, Prevention, and Mitigation 
            Program for Financial Institutions and Creditors. The 
            banking agencies, the NCUA, and the FTC also plan to issue 
            a proposed rule implementing section 114 of the FACT Act, 
            which requires the agencies to develop guidelines for use 
            in identifying patterns, practices, and specific forms of 
            activity that indicate the possible existence of identity 
            theft. The agencies are also required to issue regulations 
            requiring each financial institution and creditor to 
            establish reasonable policies and procedures to implement 
            such guidelines. The regulations must contain a provision 
            requiring a card issuer to notify the cardholder if the 
            card issuer receives a notice of change of address for an 
            existing account, and a short time later receives a request 
            for an additional or replacement card. Related to this 
            matter, the agencies are also considering issuing an 
            interpretation of section 501(b) of the Gramm-Leach-Bliley 
            Act and the Interagency Guidelines Establishing Standards 
            for Safeguarding Customer Information. This interpretation 
            would describe the agencies' expectations regarding the 
            response programs, including customer notification 
            procedures, that a financial institution should develop and 
            implement to address the unauthorized access to or use of 
            customer information that could result in substantial harm 
            or inconvenience to a customer. A proposed interpretation 
            was published for comment on August 12, 2003 (68 FR 47954).
 OTS, along with the other Federal banking agencies, plan to issue a 
final rule revising Community Reinvestment Act (CRA) rules to 
incorporate changes in the Standards for Defining Metropolitan and 
Micropolitan Statistical Areas, published by the U.S. Office of 
Management and Budget in December 2000; census tracts designated by the 
U.S. Bureau of the Census; and the Board of Governors of the Federal 
Reserve System's Regulation C, which implements the Home Mortgage 
Disclosure Act (HMDA).
 OTS is also reviewing its CRA rules to ensure that they continue to 
encourage institutions to meet their statutory responsibilities while 
affording them greater flexibility. For example, OTS is reevaluating 
how the investment test works in today's environment, including 
considering making the investment test and the lending test mutually 
available opportunities; possibly revising the definition of 
``community development'' under its CRA rules to encourage all savings 
associations to increase their community development activities in 
rural areas, with a particular focus on underserved nonmetropolitan 
areas; and encouraging institutions to perform community development 
activities in any areas affected by natural or other disasters or other 
major community disruptions.
 OTS plans to issue a proposed rule describing the existing authority 
of federal savings associations to engage in various securities broker, 
dealer, and underwriting activities under the HOLA, and requiring a 
savings association to notify OTS when it begins to conduct certain 
securities activities. The proposed rule also updates the existing 
prohibition on the sale of debt and equity securities issued by a 
savings association or its affiliates at the offices of a savings 
association, and eliminates various obsolete OTS securities 
regulations.
 Moreover, as part of its review of regulations under section 2222 of 
the Economic Growth and Regulatory Paperwork Reduction Act of 1996, OTS 
plans to issue an interim final rule to reduce regulatory burden on 
savings associations by updating and revising various application and 
reporting requirements.
Alcohol and Tobacco Tax and Trade Bureau
 The Alcohol and Tobacco Tax and Trade Bureau (TTB) issues regulations 
to enforce the Federal laws relating to the manufacture and commerce of 
alcohol products, tobacco products, and the Federal excise tax on 
firearms and ammunition. TTB's mission and regulations are designed to:
 Regulate the alcohol and tobacco industries, including systems 
            for licenses and permits;
 Assure the collection of all alcohol, tobacco, and firearms 
            and ammunition taxes, and obtain a high level of voluntary 
            compliance with all laws governing those industries;
 Suppress commercial bribery, consumer deception, and other 
            prohibited practices in the alcoholic beverage industry; 
            and
 Assist the States and other Federal agencies in their efforts 
            to eliminate interstate trafficking in, and the sale and 
            distribution of, cigarettes in avoidance of State taxes.
In 2005, TTB will continue to pursue its multi-year program of 
modernizing its regulations in title 27 of the Code of Federal 
Regulations. This program involves updating and revising the 
regulations to be more clear, current,

[[Page 72815]]

and concise, with an emphasis on the application of plain language 
principles. TTB laid the groundwork for this program in 2002 when it 
started to recodify its regulations in order to present them in a more 
logical sequence. This continuing revision effort will make the TTB 
regulations more accessible and understandable for small businesses and 
the general public.
Bureau of the Public Debt
 The Bureau of the Public Debt (BPD) administers the following 
regulations:
 Governing transactions in Government securities by Government 
            securities brokers and dealers under the Government 
            Securities Act of 1986 (GSA), as amended.
 Implementing Treasury's borrowing authority, including rules 
            governing the sale and issue of savings bonds, marketable 
            Treasury securities, and State and local Government 
            securities.
 Setting out the terms and conditions by which Treasury may 
            redeem (buy back) outstanding, unmatured marketable 
            Treasury securities through debt buyback operations.
 Governing the acceptability and valuation of all collateral 
            pledged to secure deposits of public monies and other 
            financial interests of the Federal Government.
 Treasury's GSA rules govern financial responsibility, the protection 
of customer funds and securities, recordkeeping, reporting, audit, and 
large position reporting for all government securities brokers and 
dealers, including financial institutions. During fiscal year 2005, BPD 
will give priority to expanding an exemption in the GSA regulations to 
include savings associations regulated by the Office of Thrift 
Supervision (OTS) that hold Government securities in a fiduciary and 
custodial capacity. The amendment would make savings associations 
regulated and examined by the OTS eligible for the exemption under the 
same conditions that currently apply to depository institutions 
regulated and examined by the other bank regulators.
 The rules setting out the terms and conditions for the sale and issue 
of marketable book-entry Treasury bills, notes, and bonds are known as 
the Uniform Offering Circular. During fiscal year 2005, BPD will accord 
priority to issuing an amendment to the Uniform Offering Circular that 
would treat two parties in a merchant banking relationship as separate 
bidders rather than as a single bidder in Treasury marketable 
securities auctions.
Financial Management Service
 The Financial Management Service (FMS) issues regulations to improve 
the quality of Government financial management and to administer its 
payments, collections, debt collection, and Governmentwide accounting 
programs.
 During fiscal year 2005, FMS' regulatory priorities include ongoing 
initiatives in the following areas:
 Payment of Federal Taxes and the Treasury Tax and 
            Loan Program (TT&L) (31 CFR Part 203): FMS is completing 
            its revisions to this rule that governs the collection of 
            corporate withholding taxes and the investment of the 
            Government's excess operating funds. FMS is streamlining 
            this rule and writing it in plain language.
 Automated Clearing House (ACH) (31 CFR Part 210): 
            FMS will issue its annual update to this rule that 
            establishes standards for Federal Government payments and 
            collections via the ACH system. FMS will revise this rule 
            in order to stay current with private industry rules and to 
            facilitate the continued expansion of electronic commerce.
_______________________________________________________________________



TREAS--Comptroller of the Currency (OCC)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




113. IMPLEMENTATION OF A REVISED BASEL CAPITAL ACCORD (BASEL II)
Priority:


Economically Significant. Major status under 5 USC 801 is undetermined.


Legal Authority:


12 USC 93a; 12 USC 3907


CFR Citation:


12 CFR 3


Legal Deadline:


None


Abstract:


As part of the OCC's ongoing efforts to develop and refine capital 
standards to ensure the safety and soundness of the national banking 
system and to implement statutory requirements, the OCC is amending 
various provisions of the capital rules for national banks. This change 
involves the implementation of the new Basel Capital Accord (Basel II) 
(formerly referred to as domestic capital framework). The OCC is 
conducting this rulemaking jointly with the other Federal banking 
agencies.


Statement of Need:


This rulemaking is necessary to implement an international initiative 
regarding the capital adequacy regulation of certain domestic financial 
institutions. Specifically, this rulemaking implements the 
``International Convergence of Capital Measurement and Capital 
Standards'' (Basel II), which comprehensively revises the 1988 
``International Convergence of Capital Measurement and Capital 
Standards.'' This rulemaking will translate the lengthy and complicated 
text of Basel II into the standards and requirements that will govern 
the largest banks in the United States.


Summary of Legal Basis:


The OCC is implementing the Basel II capital framework for certain 
domestic financial institutions. This initiative is based on the OCC's 
general rulemaking authority in 12 U.S.C. 93a and its specific 
authority under 12 U.S.C. 3907. 12 U.S.C. 3907(a)(2) specifically 
authorizes the OCC to establish minimum capital levels for financial 
institutions that the OCC, in its discretion, deems necessary or 
appropriate.


Alternatives:


Not yet determined.


Anticipated Cost and Benefits:


Not yet determined.


Risks:


Not yet determined.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           68 FR 45900                                    08/04/03
NPRM                                                           08/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None

[[Page 72816]]

Agency Contact:
Ron Shimabukuro
Special Counsel
Department of the Treasury
Comptroller of the Currency
Legislative and Regulatory Activities Division
250 E Street SW.
Washington, DC 20219
Phone: 202 874-5090
Fax: 202 874-4889
Email: [email protected]
Related RIN: Split from 1557-AB14
RIN: 1557-AC91
BILLING CODE 4810-25-S

[[Page 72817]]




DEPARTMENT OF VETERANS AFFAIRS (VA)



Statement of Regulatory Priorities
 The Department of Veterans Affairs (VA) administers benefit programs 
that recognize the important public obligations to those who served 
this Nation. VA's regulatory responsibility is almost solely confined 
to carrying out mandates of the laws enacted by Congress relating to 
programs for veterans and their beneficiaries. VA's major regulatory 
objective is to implement these laws with fairness, justice, and 
efficiency.
 Most of the regulations issued by VA involve at least one of three VA 
components: The Veterans Benefits Administration, the Veterans Health 
Administration, and the National Cemetery Administration. The primary 
mission of the Veterans Benefits Administration is to provide high-
quality and timely nonmedical benefits to eligible veterans and their 
beneficiaries. The primary mission of the Veterans Health 
Administration is to provide high-quality health care on a timely basis 
to eligible veterans through its system of medical centers, nursing 
homes, domiciliaries, and outpatient medical and dental facilities. The 
primary mission of the National Cemetery Administration is to bury 
eligible veterans, members of the Reserve components, and their 
dependents in VA National Cemeteries and to maintain those cemeteries 
as national shrines in perpetuity as a final tribute of a grateful 
Nation to honor the memory and service of those who served in the Armed 
Forces.
 VA's regulatory priorities include a special project to undertake a 
comprehensive review and improvement of its existing regulations. The 
first portion of this project is devoted to reviewing, reorganizing, 
and rewriting the VA's compensation and pension regulations found in 
part 3 of 38 CFR. The goal of the Regulation Rewrite Project is to 
improve the clarity and logical consistency of these regulations in 
order to better inform veterans and their family members of their 
entitlements.
The Department of Veterans Affairs' 2004 regulatory plan contains one 
rulemaking action from the Veterans Health Administration. The Veterans 
Health Administration rulemaking is RIN 2900-AL51 ``Enrollment--
Provision of Hospital and Outpatient Care to Veterans Subpriorities of 
Priority Categories 7 and 8 and Annual Enrollment Level Decision,'' 
which was published as an interim final rule on January 17, 2003. It 
amends the Department's medical regulations to protect the quality and 
improve the timeliness of care provided to all veterans by restricting 
new enrollments in higher enrollment-priority categories.
_______________________________________________________________________



VA

                              -----------

                            FINAL RULE STAGE

                              -----------




114. ENROLLMENT--PROVISION OF HOSPITAL AND OUTPATIENT CARE TO 
VETERANS--SUBPRIORITIES OF PRIORITY CATEGORIES 7 AND 8 AND ENROLLMENT 
LEVEL DECISION
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


PL 104-262


CFR Citation:


38 CFR 17.36


Legal Deadline:


None


Abstract:


The Department of Veterans Affairs (VA) published in the Federal 
Register on January 17, 2003, an interim final rule amending VA's 
medical regulations at 38 CFR part 17 to establish additional 
subpriorities within enrollment priority categories 7 and 8 and to 
provide that, beginning January 17, 2003, VA will continue to treat all 
veterans currently enrolled in any category, and will treat new 
enrollees in categories 1 through 7. However, the interim final rule 
provided that VA will suspend the enrollment of additional veterans who 
are in the lowest statutory enrollment category (priority category 8). 
Based on the rationale set forth in the interim final rule, VA is 
adopting the provisions of the interim final rule as a final rule 
without change.


Statement of Need:


Public Law 104-262, the Veterans' Health Care Eligibility Reform Act of 
1996, requires the Secretary of Veterans Affairs to make annual 
decisions concerning enrollment in VA's health care system in order to 
ensure that resources are available to provide medical services that 
are both timely and acceptable in quality. This document announces the 
enrollment decision to suspend the enrollment of additional veterans 
who are in the lowest statutory enrollment category (priority category 
8). This also amends existing regulations to establish additional 
subpriorities within priority categories 7 and 8.


Summary of Legal Basis:


38 CFR 17.36(c) requires that the Secretary determine which categories 
of veterans are eligible to be enrolled and that the Secretary notify 
eligible enrollees of the determination by announcing it in the Federal 
Register.


Alternatives:


The Department had to consider placing additional enrollees on waiting 
lists and extending the waiting period for eligible enrollees seeking 
appointments for care as alternatives.


Anticipated Cost and Benefits:


By suspending enrollment of additional priority category 8 veterans, VA 
would avoid significant additional medical benefits costs and begin to 
bring demand in line with capacity, which will reduce the number of 
veterans on waiting lists. Without action to suspend new enrollment, 
the cost projection for FY 2003 is $23.455 billion. This is based on 
the projected average enrollment for FY 2003 of 6,991,405, together 
with the projected expenditures that would be needed to provide the 
medical benefits package to all enrollees. Suspending new enrollment 
would reduce enrollment in priority category 8 by 164,367 in FY 2003, 
which is expected to grow to over 520,000 by FY 2005.


Risks:


Without action to suspend new enrollment, patient safety and quality 
and access to care would be adversely affected.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Interim Final Ru68 FR 2670                                     01/17/03
Interim Final Rule Effective                                   01/17/03
Interim Final Rule Comment Period End                          03/18/03
Final Action                                                   12/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None

[[Page 72818]]

URL For Public Comments:
www.regulations.gov
Agency Contact:
Ruth Hoffman
Office of the Assistant Deputy Secretary for Health (10A5A)
Department of Veterans Affairs
Veterans Health Administration
810 Vermont Avenue NW
Washington, DC 20420
Phone: 202 273-8934
RIN: 2900-AL51
BILLING CODE 8320-01-S

[[Page 72819]]




ENVIRONMENTAL PROTECTION AGENCY (EPA)



Environmental Protection Agency
Statement of Priorities
OVERVIEW
 The U.S. Environmental Protection Agency (EPA) is the leading Federal 
agency responsible for protecting human health and the environment. 
Since its creation in 1970, EPA has taken actions that have led to 
measurable improvements in air and water quality, significant 
reductions in solid and hazardous wastes, and limitations on the use of 
harmful chemicals and pesticides.
 Specifically, EPA leads the nation's environmental science, research, 
education and assessment efforts by:
Developing and enforcing regulations: EPA works to develop and enforce 
regulations that implement environmental laws enacted by Congress. EPA 
is responsible for researching and setting national standards for a 
variety of environmental programs, and delegates to States and tribes 
the responsibility for issuing permits and for monitoring and enforcing 
compliance. Where national standards are not met, EPA can issue 
sanctions and take other steps to assist the states and tribes in 
reaching the desired levels of environmental quality.
Offering financial assistance: In recent years, between 40 and 50 
percent of EPA's enacted budgets have provided direct support through 
grants to State environmental programs. EPA grants to States, non-
profits and educational institutions support high-quality research that 
will improve the scientific basis for decisions on national 
environmental issues and help EPA achieve its goals.
 EPA provides research grants and graduate fellowships.
 The Agency supports environmental education projects that 
            enhance the public's awareness, knowledge, and skills to 
            make informed decisions that affect environmental quality.
 The Agency also offers information for State and local 
            governments and small businesses on financing environmental 
            services and projects.
 EPA also provides other financial assistance through programs 
            as the Drinking Water State Revolving Fund, the Clean Water 
            State Revolving Fund, and the Brownfields program.
Performing environmental research: At laboratories located throughout 
the nation, the Agency works to assess environmental conditions and to 
identify, understand, and solve current and future environmental 
problems; integrate the work of scientific partners such as nations, 
private sector organizations, academia and other agencies; and provide 
leadership in addressing emerging environmental issues and in advancing 
the science and technology of risk assessment and risk management.
Sponsoring voluntary partnerships and programs: The Agency works 
through its headquarters and regional offices with over 10,000 
industries, businesses, non-profit organizations, and state and local 
governments, on over 40 voluntary pollution prevention programs and 
energy conservation efforts. Partners set voluntary pollution-
management goals; examples include conserving water and energy, 
minimizing greenhouse gases, slashing toxic emissions, re-using solid 
waste, controlling indoor air pollution, and getting a handle on 
pesticide risks. In return, EPA provides incentives like vital public 
recognition and access to emerging information.
Furthering environmental education: EPA advances educational efforts to 
develop an environmentally conscious and responsible public, and to 
inspire personal responsibility in caring for the environment.
 To view the Agency's complete strategic plan and annual report, go to 
http://www.epa.gov/ocfopage/plan/plan.htm.
FOCUSING ON A BETTER WAY
 EPA is focusing on finding a better way of environmental protection, 
one that can accelerate environmental progress. The existing system has 
served the nation well . . . but today's challenges are more complex. 
New approaches are needed that can help achieve goals more quickly and 
cost-effectively. EPA is relying on four cornerstones to finding a 
better way - Collaborative problem-solving, market incentives, new 
technology, and a focus on results.
 Collaborative problem-solving is a way of achieving more with our 
collective resources - bringing all available expertise and resources 
to bear in solving problems. For example, EPA is collaborating with 
States and other partners in an effort to improve the Great Lakes and 
scaling up its National Environmental Performance Track Program. 
Performance Track is the flagship EPA voluntary program that recognizes 
and rewards top-performing facilities representing all sizes of 
businesses from a variety of sectors. This program provides public 
recognition to these entities and offers regulatory, policy, and 
administrative incentives, such as a low priority for routine EPA 
inspections, extended on-site storage times for hazardous waste, and 
reduced reporting frequency under the Clean Air Act.
 Incentives are the second cornerstone. Market-based approaches or 
other incentives can lead businesses, government agencies, and other 
organizations to do more than is required. These approaches provide a 
way to link environmental and economic interests so that doing more for 
the environment nets more for the bottom line. EPA is working to build 
more incentives into our programs and policies. For example, EPA is 
proposing to use market-based approaches to drastically reduce 
emissions of mercury, SOx and NOx.
 Technology is the third cornerstone. To continue making progress, it 
is critical to harness the latest scientific, technological, and 
information capabilities for environmental gain. For example under our 
Technology for a Sustainable Environment (TSE) program, after a 
competition, we award grants to support fundamental and applied 
research related to pollution prevention in industrial processes and 
methodologies ultimately leading to a reduction in waste at the source. 
Under this program, as an alternative to organic or halogenated 
solvents, a CO2-based process was developed. The work was further 
supported with a Small Business Innovation Research grant and now a 
$400 million commercial facility is being built to exploit it.
 Focus on results is the fourth cornerstone. EPA understands that 
traditional environmental strategies have sometimes gotten bogged down 
in process at the expense of real progress. One of the best examples is 
reducing dirty emissions from older diesel school buses. Recognizing 
diesel engines have long life spans - sometimes 30 years - and that 
many school systems would use current buses until they had ``run their 
course,'' EPA launched a nationwide campaign to retrofit older buses 
and provide our children with a much cleaner, healthier ride to school. 
Hundreds of communities now have retrofitting programs underway.
 EPA believes these cornerstones will be the foundation to finding a 
better way to environmental progress.
Attention to Small Businesses

[[Page 72820]]

 Helping small businesses improve environmental performance is a top 
priority for EPA. EPA offers a variety of services for small 
businesses, including a toll-free hotline, a semiannual newsletter, 
online expert systems, and for some sectors, compliance assistance 
centers that focus on the unique environmental management issues facing 
specific industries. EPA also maintains a Small Business Ombudsman, 
which provides a point of contact for small businesses and ensures 
compliance with the Small Business Paperwork Relief Act of 2002.
 In FY 2004, EPA is focusing on implementing the Small Business 
Strategy. By better coordinating small business activities, EPA aims to 
improve its technical assistance and outreach efforts, minimize burdens 
to small businesses in its regulations, and simplify small businesses' 
participation in its voluntary programs.
 A number of rules included in this Plan may be of particular interest 
to small businesses (and for a more extensive list of rules affecting 
small businesses, please see appendices B and C to the Regulatory 
Agenda which is available at epa.gov/regagenda.)
 Groundwater Rule (2040-AA97)
 Long Term 2 Enhanced Surface Water Treatment Rule (2040-AD37)
 Stage 2 Disinfection Byproducts Rule (2040-AD38)
 Minimizing Adverse Environmental Impacts from Cooling Water 
            Intake Structures (316(b) Phase III) Rule (2040-AD70)
 Standardized Permit for RCRA Hazardous Waste Management 
            Facilities Final Rule (2050-AE44)
 Office of Solid Waste Burden Reduction Project Final Rule 
            (2050-AE51)
 Recycling of Cathode Ray Tubes and Mercury-Containing 
            Equipment: Changes to Hazardous Waste Regulations Final 
            Rule (2050-AE52)
 Increase Metals Reclamation from F006 Waste Streams Proposed 
            Rule (2050-AE97)
 Standards and Practices for Conducting ``All Appropriate 
            Inquiry'' Proposed Rule (2050-AF04)
 Control of Emissions from Spark-Ignition Engines and Fuel 
            Systems from Marine Vessels and Small Equipment (2060-AM34)
HIGHLIGHTS OF EPA'S REGULATORY PLAN
 Office of Air and Radiation
 The principal regulatory priority of EPA's Office of Air and Radiation 
(OAR) for FY 2005 is to protect public health and the environment from 
the harmful effects of fine particulate matter and ozone, the two air 
pollutants that persist widely in the Nation's air in amounts that 
exceed Clean Air Act health standards. Exposure to these pollutants is 
associated with numerous harmful effects on human health, including 
respiratory problems, heart and lung disease, and premature death. 
These pollutants also degrade visibility in National parks and other 
scenic areas. In addition to ozone and particulate pollution, OAR is 
continuing to address toxic air pollution by implementing a toxics-
control program under the Clean Air Act. OAR is also working to 
increase the effectiveness and efficiency of its permitting programs, 
which are the main mechanisms through which these protections are 
implemented. These efforts are described briefly below.
 One of OAR's principal vehicles to mitigate particulate and ozone 
pollution is the Clean Air Interstate Rule, which will achieve large 
reductions in sulfur dioxide and nitrogen oxide emissions that cause 
particulate and ozone pollution. Emissions of sulfur dioxide and 
nitrogen oxide, especially from electric powerplants, can be 
transported on the wind over long distances from the Midwest to the 
east coast. Such emissions can be a major factor in the pollution 
problems of eastern cities. This program will achieve its reductions 
through use of a ``cap-and-trade'' system similar to the one that has 
proved so successful in EPA's Acid Rain program. OAR is also developing 
a separate rule to enhance scenic areas by reducing the particulate 
pollution that restricts visibility in those areas.
 OAR is also developing a rulemaking addressing another category of 
emissions that cause particulate and ozone pollution: emissions from 
locomotives and smaller marine engines. This rule will enhance the 
overall mobile-source control program that has already set stringent 
standards for most categories of vehicles, engines, and their fuels.
 Even though these Federal rules will go a long way toward reducing the 
ozone and particulate pollution in America's cities, they can't do the 
job alone. Additional State and local control programs under the Clean 
Air Act will need to be instituted or enhanced in many of the most 
polluted areas. To help and guide the States and local governments in 
these efforts, EPA is developing implementation rulemakings for both 
ozone and particulates that will provide technical help and policy 
guidance crucial to assuring that State and local efforts achieve their 
pollution-control goals.
 OAR also continues to assess new scientific information that underlies 
the National Ambient Air Quality Standards (NAAQS), which are the 
centerpiece of the Clean Air Act and the foundation of OAR's program. 
In 2005, EPA expects to announce the results of the latest review of 
the particulate matter NAAQS in the form of a proposed rule to either 
revise or reaffirm the current standard.
 EPA continues to address toxic air pollution under authority of the 
Clean Air Act Amendments of 1990. EPA has largely completed 
implementing the ``Maximum Achievable Control Technology'' (MACT) 
program, which has the goal of controlling toxic air pollution from 
major emitters nationwide. Toxic air pollution is a term that covers a 
large number of industrial chemicals and other substances that have 
been shown to cause cancer, birth defects, and developmental problems 
in children. To date, EPA's air toxics program has focused primarily on 
reducing emissions from large industrial sources, such as petroleum 
refineries and chemical manufacturing plants, through technology-based 
standards. When fully implemented, the overall MACT program will reduce 
more than one million tons of toxic air emissions per year. The 
Electric Utility MACT regulation will address one of the most 
significant remaining sources of mercury in the United States. While 
working on these standards, OAR is beginning to evaluate those sources 
with standards already in place to determine if the remaining risk from 
those sources warrants additional regulation.
 Since many air quality programs are administered through permitting 
programs, OAR continues to work toward improving these programs to 
increase efficiency and reduce regulatory burden. Currently, OAR is 
developing rulemakings to streamline and improve its New Source Review 
(NSR) permitting program. This effort will clarify the circumstances 
under which companies must obtain construction permits before building 
new facilities or significantly modifying existing facilities. These 
revisions will provide more regulatory certainty by clarifying 
compliance requirements, and will also make the program easier to

[[Page 72821]]

administer while maintaining its environmental benefits. In developing 
these NSR rule revisions, OAR is drawing upon many years of intense 
involvement with major stakeholders, who have helped shape a suite of 
reforms that are expected to both improve the environmental 
effectiveness of these programs and make them easier to comply with.
 The annual report on the costs and benefits of regulations, entitled 
``Stimulating Smarter Regulation: 2002 Report to Congress on the Costs 
and Benefits of Regulations and Unfunded Mandates on State, Local, and 
Tribal Entities,'' that is prepared by the Office of Management and 
Budget (OMB) and submitted to Congress each year, included several 
nominations for reform from the public. In FY2005, OAR expects to 
address through regulatory action one of the areas raised: New Source 
Review (Comments 16, 30, 77, 187, 188, 189, and 196). (For a 
copy of these comments, go to OMB's compilation of the comments at 
http://www.whitehouse.gov/omb/inforeg/key--comments.html.)
Office of Environmental Information
 EPA's Office of Environmental Information (OEI) continues to ensure 
that EPA collects and provides access to high quality environmental 
information and data to our partners, stakeholders, and the public. In 
keeping with this mandate, one of OEI's top regulatory priorities will 
be the finalization of the electronic reporting provisions of the 
Cross-Media Electronic Reporting and Record-Keeping Rule (CROMERRR). 
EPA is deferring any further action on the CROMERRR electronic record-
keeping provisions until a later time. This final rule will address 
electronic reporting by companies regulated under all of EPA's 
programs: air, water, pesticides, toxic substances, wastes, and 
emergency response. CROMERRR would remove existing regulatory obstacles 
to electronic reporting, and it would set requirements for companies 
choosing to report electronically. In addition, this rule would set the 
conditions for allowing electronic reporting under State, tribal, or 
local environmental programs that operate under EPA authorization.
 CROMERRR is intended to make electronic reporting as simple, 
efficient, and cost-effective as possible for regulated companies, 
while ensuring that a transition from paper to electronic reporting 
does not compromise EPA's compliance and enforcement programs. 
Consequently, the Agency's strategy is to impose as few specific 
requirements as possible, and to keep those requirements neutral with 
respect to technology, so the rule will pose no obstacles to adopting 
new technologies as they emerge.
 To ensure that authorized programs at the State, tribal, and local 
levels meet CROMERRR's goals, the rule would specify a set of criteria 
that these programs must satisfy as they initiate electronic reporting. 
The final rule would specify a process for certifying that these 
programs meet the criteria. EPA is on schedule to finalize CROMERRR by 
the first half of FY2005. In response to public comment, a decision was 
made to focus the final rule on electronic reporting only, and to defer 
coverage of electronic record keeping until a later time. Also in 
response to comments, EPA currently is exploring a streamlined process 
to review State programs for electronic reporting.
 Another key regulatory priority that OEI is undertaking is the 
enactment of burden reduction for the Toxics Release Inventory (TRI) 
reporting community. The TRI program collects chemical release and 
other waste management data on over 650 chemicals from over 24,000 
facilities across the U.S. each year. To provide TRI reporters with 
appropriate burden relief, TRI intends to propose two rulemakings to 
address both short-term and longer-term reporting requirement 
modifications while maintaining the practical utility of the TRI data. 
Specifically, OEI intends to propose the TRI Reporting Forms 
Modification rule to address noncontroversial modifications to the TRI 
reporting requirements (i.e., Form R). At the same time, OEI intends to 
continue parallel work on a second rulemaking to examine more 
significant reporting modifications with greater potential impact on 
reporting burden. The second rulemaking, the ``Toxics Release Inventory 
Reporting Burden Reduction Rule,'' focuses on exploring long-term 
reporting modifications.
 OEI is assessing a number of burden reduction options for both 
rulemakings within the criteria of what is technically, practically and 
legally feasible in order to meet the goals and statutory obligations 
set forth for TRI reporting. Although the primary goal of both efforts 
is to reduce burden associated with TRI reporting, these rules will 
also maintain EPA's commitment to providing valuable information to the 
public.
 In addition, EPA is committed to providing electronic means to its 
stakeholders to meet EPA's reporting requirements, specifically through 
the Central Data Exchange (CDX) system. CDX is an integrated system 
that provides electronic reporting services to more than 30,000 users 
for 16 data flows in six major EPA media programs, and is on track to 
provide electronic reporting services for all significant environmental 
data collections over the next two years. By enabling the regulated 
community to utilize CDX as a reporting tool, the TRI Program has seen 
a 49% increase in the number of reports submitted to EPA via the 
Internet for TRI Reporting Year 2003 when compared to Reporting Year 
2002. To take advantage of CDX's paperless reporting feature, TRI 
reporters must use the EPA-provided TRI Made-Easy (TRI-ME) Software. 
This upward trend toward greater Internet reporting via CDX is great 
news for the TRI program. Money saved from processing more-costly hard-
copy paper submissions to TRI can now be reinvested in helpful tools 
and automated data quality checks to assist facilities and in ways to 
provide greater electronic means of accessing TRI data.
 CDX also promulgated a number of new data flows, including the Office 
of Water's Stormwater Electronic Notice of Intent (an electronic permit 
application), the Office of Solid Waste and Emergency Response's Risk 
Management Plan WebRC (electronic updates of emergency contact 
information), and the Office of Prevention, Pesticides, and Toxic 
Substances' Lead Request for Certification (payment transactions 
online).
 CDX is EPA's point of presence on the Environmental Exchange Network, 
known as the ``Node.'' Using CDX, EPA has worked with States to provide 
the technical specifications and exchange protocols for the Network. 
CDX provides support services, including node building, security and 
authentication and help desk. OEI is working with the major programs to 
deploy their data flows as ``node'' exchanges, using XML and web 
services. These efforts are some examples of EPA's commitment to the 
collection and dissemination of the highest quality of environmental 
information.
Office of Prevention, Pesticides, and Toxic Substances
 EPA's Office of Prevention, Pesticides, and Toxic Substances (OPPTS) 
plays an important role in protecting public health and the environment 
from potential risk from pesticides and chemicals. In addition to the 
daily

[[Page 72822]]

activities related to our licensing programs, OPPTS has identified 
several regulatory priorities for the coming year.
 Evidence suggests that environmental exposure to man-made chemicals 
that mimic hormones (endocrine disruptors) may cause adverse health 
effects in human and wildlife populations. The Food Quality Protection 
Act directed EPA to develop a chemical screening program (the Endocrine 
Disruptor Screening Program, EDSP), using appropriate validated test 
systems and other scientifically relevant information, to determine 
whether certain substances may have hormonal effects in humans. OPPTS 
is implementing recommendations from a scientific advisory committee, 
which was established to advise EPA on the EDSP, by developing and 
validating test systems for determining whether a chemical may have 
effects similar to those produced by naturally occurring hormones. As 
part of this program EPA is also designing a regulatory framework for 
procedures and processes to use when implementing the EDSP, and will 
develop an initial list of chemicals for which testing will be 
required. In early 2005, EPA anticipates publishing the final chemical 
selection approach for this initial list of chemicals, which was 
proposed in December 2002 for public comment.
 In 2005, OPPTS will be revising its pesticide emergency exemption 
program, under which States and other Federal agencies may obtain 
permission to temporarily use a pesticide not in accordance with 
registration requirements under emergency conditions. In response to 
State concerns, EPA has already reduced the review time for emergency 
exemptions significantly. Other changes that EPA is considering have 
the potential for further streamlining the exemption program and 
allowing more flexibility in its applicability.
 OPPTS will propose to update and revise data requirements for the 
registration of pesticide products in 40 CFR part 158. The regulations 
specify the data required as the basis for the Agency's pesticide risk 
assessment and licensing decisions. Although the Agency has kept pace 
with evolving scientific understanding of pesticide risks by requiring 
the submission of data on a case-by-case basis, the 1984 regulations 
have not been updated to reflect these data needs on a routine basis. 
The first in a series of proposals will address data requirements for 
conventional chemical pesticides for agricultural uses. Subsequent 
proposals are planned for antimicrobial, biochemical, microbial 
pesticides, and plant-incorporated protectants.
 In 2006, OPPTS will begin implementing a program, mandated by section 
3(g) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), 
to review the registrations of all pesticides at least once each 15 
years. The registration review program will replace the tolerance 
reassessment program (ending in 2006) and reregistration program 
(ending in 2008) currently underway. These two programs are both one-
time reviews that evaluate and manage the risks posed by existing 
pesticides. The Agency intends to initiate registration review while it 
completes tolerance reassessment and reregistration. FIFRA 3(g) 
requires the Agency to establish procedural regulations for the 
registration review program. Promulgation of a procedural regulation is 
a very high priority for OPP, in order to achieve a smooth transition 
into the new registration review program.
 EPA anticipates it will develop a policy or regulation concerning the 
use of human research to support Agency actions to protect public 
health and the environment. In developing a future policy or rule, EPA 
will consider the public comments received in response to the Advance 
Notice of Proposed Rulemaking issued in May 2003, and will also 
carefully consider advice from the National Academy of Sciences 
submitted to EPA in February 2004. The policy or rule would establish 
rigorous scientific and ethical standards that EPA would apply in its 
analysis of various types of research involving people exposed to 
toxicants to identify or quantify their effects. The Agency will 
particularly focus on ``third-party intentional dosing human studies,'' 
but recognizes that standards applicable to these studies may also be 
applicable to other types of studies. ``Third-party studies'' refers to 
research not conducted or supported by EPA or other federal agencies, 
and therefore not governed by the regulation for ``Protection of Human 
Subjects,'' widely referred to as the ``Common Rule'' (40 CFR part 26).
 The Agency launched the HPV Initiative in April 1998 to collect or, 
where necessary, develop basic screening level hazard data necessary to 
provide critical information about the environmental fate and potential 
hazards associated with high production volume (HPV) chemicals. These 
chemicals are defined as organic chemicals manufactured (including 
imported) at or above 1 million pounds per year based on information 
submitted under the 1990 Inventory Update Rule established pursuant to 
the Toxic Substances Control Act (TSCA). Data collected and/or 
developed under the HPV Initiative will provide critical basic 
information about the environmental fate and potential hazards 
associated with these chemicals which, when combined with information 
about exposure and uses, will allow the Agency and others to evaluate 
and prioritize potential health and environmental effects and take 
appropriate follow up action. The HPV Initiative includes a voluntary 
component, the HPV Challenge Program, and rulemaking under TSCA. Under 
the voluntary HPV Challenge Program component, EPA received commitments 
from 401 companies individually or through consortia and the 
International Council of Chemical Associations (ICCA) to sponsor 2,222 
of the estimated 2,800 HPV chemicals included in the HPV Initiative. 
OPPTS issued a status report for the HPV Challenge Program on December 
1, 2004. The report, ``Status and Future Directions of the HPV 
Challenge Program,'' showcases the extensive voluntary participation by 
companies that have agreed to provide data to EPA on chemicals they 
manufacture or import, and outlines a preliminary strategy for how EPA 
will deal with chemicals that are not yet sponsored. More information 
about the report and the HPV Chemical Program is available at http://
www.epa.gov/chemrtk/hpvstatr.htm.
In the spring of 2005, OPPTS expects to issue a final rulemaking under 
TSCA that will require testing for a number of the HPV chemicals that 
were not sponsored as part of the voluntary HPV Challenge Program.
 Childhood lead poisoning is an ongoing problem in the United States, 
with almost a million young children having more than 10 ug/dl of lead 
in their blood (Center for Disease Control's level of concern). 
Although there have been dramatic declines in blood-lead levels due to 
reductions of lead in paint, gasoline and various food sources, 
remaining lead-based paint in older houses continues to be a 
significant source of childhood lead poisoning. Section 402(c) of TSCA 
directs EPA to address renovation and remodeling activities in these 
older houses by first conducting a study of the extent to which persons 
engaged in various types of renovation and remodeling activities

[[Page 72823]]

are exposed to lead in the conduct of such activities or disturb lead 
and create a lead-based paint hazard on a regular basis. Section 402(c) 
further directs the Agency to revise the lead-based paint activities 
regulations (40 CFR part 745 Subpart L) to include renovation or 
remodeling activities that create lead-based paint hazards. In order to 
determine which contractors are engaged in such activities the Agency 
is directed to utilize the results of the study and consult with the 
representatives of labor organizations, lead-based paint activities 
contractors, persons engaged in remodeling and renovation, experts in 
health effects, and others. Given the significant number of older 
houses affected, such a rule is likely to have a potentially 
significant economic impact. In an effort to minimize that impact, the 
Agency has worked with stakeholders to explore the development of non-
regulatory approaches for reducing the potential creation of lead-based 
paint hazards from renovation or remodeling activities. The Agency will 
be pilot testing one such approach, the ``Lead Safety Partnership,'' 
beginning in the fall of 2004. The Lead Safety Partnership is a public/
private initiative to encourage contractors to use Lead Safe Work 
Practices (LSWP) during renovation, repair, and painting. LSWP are a 
set of work methods that avoid making and spreading lead-contaminated 
dust. Such lead-based paint program activities are intended to insure 
that the individuals and firms conducting lead-based paint activities 
will do so in a way that safeguards the environment and protects the 
health of building occupants, especially children under six years old.
 In 2005, OPPT expects to assess the status of the pending 
implementation in the U.S. of the Rotterdam Convention on Prior 
Informed Consent (PIC), which includes export notification requirements 
related to a comment mentioned in OMB's 2002 Report to Congress on the 
Costs and Benefits of Regulations. (See OMB's compilation of comments, 
summary no. 190, page 10, commenter no. 12 available at http://
www.whitehouse.gov/omb/inforeg/key--comments.html.)
 The Agency launched the HPV Initiativein April 1998 to collect or, 
where necessary, develop basic screening level hazard data necessary to 
provide critical information about the environmental fate and potential 
hazards associated with high production volume (HPV) chemicals. These 
chemicals are defined as organic chemicals manufactured (including 
imported) at or above 1 million pounds per year based on information 
submitted under the 1990 Inventory Update Rule established pursuant to 
the Toxic Substances Control Act (TSCA). Data collected and/or 
developed under the HPV Initiative will provide critical basic 
information about the environmental fate and potential hazards 
associated with these chemicals which, when combined with information 
about exposure and uses, will allow the Agency and others to evaluate 
and prioritize potential health and environmental effects and take 
appropriate follow up action. The HPV Initiative includes a voluntary 
component, the HPV Challenge Program, and rulemaking under TSCA. Under 
the voluntary HPV Challenge Program component, EPA received commitments 
from 401 companies individually or through consortia and the 
International Council of Chemical Associations (ICCA) to sponsor 2,222 
of the estimated 2,800 HPV chemicals included in the HPV Initiative. 
OPPTS anticipates issuing a status report for the HPV Challenge Program 
in the fall of 2004. In the spring of 2005, OPPTS expects to issue a 
final rulemaking under TSCA that will require testing for a number of 
the HPV chemicals that were not sponsored as part of the voluntary HPV 
Challenge Program.
Office of Solid Waste and Emergency Response
 The Office of Solid Waste and Emergency Response (OSWER) has a number 
of regulatory priorities aimed at improving environmental quality. 
Protection of public health and the environment and environmental 
stewardship are two key themes, as is reducing burden on the regulated 
community where environmental protections are maintained.
 EPA will promote and protect air quality by reducing emissions of 
arsenic, beryllium, cadmium, chromium, dioxins and furans, hydrogen 
chloride, lead, manganese, and mercury, all of which cause adverse 
health effects. EPA plans to promulgate national emission standards for 
these hazardous air pollutants for hazardous waste combustors. This 
rule will also contain a final decision to the Cement Kiln Recycling 
Coalition petition of the Administrator to withdraw Agency policy and 
technical guidance concerning site-specific risk assessments for 
hazardous waste combustors and re-issue them as regulations, if EPA 
continues to believe that they are necessary. This rule also supports a 
reform nomination for site-specific risk assessments in the Resource 
Conservation and Recovery Act (RCRA) that was mentioned in OMB's 2002 
Report to Congress on the Costs and Benefits of Regulations.
 To promote environmental stewardship, EPA is encouraging recycling. 
One of the largest hazardous waste streams amenable to recycling is the 
wastewater treatment sludges from electroplating operations (waste code 
F006). EPA is considering changes to the existing RCRA regulations to 
encourage safe recycling and waste management practices of wastewater 
treatment sludges from electroplating operations. These electroplating 
sludges are sufficiently high in metal(s) and sufficiently low in other 
toxic constituents.
 EPA also seeks to remove unnecessary regulatory barriers to recycling 
of Cathode Ray Tubes. These tubes, which are found in televisions and 
computer monitors, contain lead to protect users from x-rays. To 
promote recycling, EPA will seek to streamline RCRA requirements for 
managing mercury-containing equipment.
 To reduce burden on the regulated community, Agency efforts are 
underway to eliminate duplicative and non-essential paperwork burden 
imposed by RCRA reporting and recordkeeping requirements. This rule 
will eliminate or streamline paperwork requirements that are 
unnecessary because they add little to the protectiveness of the RCRA 
regulations. This rule also supports a reform nomination for burden 
reduction under RCRA that was mentioned in OMB's 2002 Report to 
Congress on the Costs and Benefits of Regulations.
 EPA also intends to reduce burden on the regulated community by 
revising the current RCRA regulations that apply to the wastewater 
treatment sludges from the chemical conversion coating (zinc 
phosphating) of aluminum. The current federal regulations require that 
the wastewater treatment sludges generated from this conversion coating 
process be managed as a RCRA hazardous waste. Yet, such sludges do not 
contain the constituents for which the F019 hazardous waste was 
originally listed (cyanide and chromium).
 EPA also plans to streamline both the RCRA permit and hazardous waste 
manifest processes. The Agency is creating a standardized permit for 
RCRA facilities that generate hazardous waste and routinely manage the 
waste on-site in tanks, containers, and containment

[[Page 72824]]

buildings. This standardized permit process would allow facilities to 
obtain and modify permits more easily while maintaining the 
protectiveness currently existing in the individual RCRA permit 
process.
 Likewise, the Agency plans to reduce paperwork burden by standardizing 
the Uniform Hazardous Waste Manifest, which is a multi-copy form used 
to identify the quantity, composition, origin, routing, and destination 
of RCRA hazardous waste during its transportation. EPA plans to specify 
one format for the manifests that may be used in all states. EPA is 
working toward standard requirements for tracking rejected wastes, 
container residues, and international shipments of hazardous wastes.
Office of Water
 EPA's Office of Water's primary goals are to ensure that drinking 
water is safe, restore and maintain oceans, watersheds, and their 
aquatic ecosystems to protect human health, support economic and 
recreational activities, and provide healthy habitat for fish, plants, 
and wildlife. In order to meet these goals, EPA has established a 
number of regulatory priorities for the coming year. They include rules 
affecting cooling water intakes and drinking water.
 In November 2004, EPA issued a proposed rule to control the adverse 
environmental impacts associated with cooling water intakes. Many power 
plants and factories withdraw large volumes of water from rivers, 
lakes, or other water bodies to cool their production equipment. As 
required by the Clean Water Act (CWA), EPA must ensure that the 
location, design, construction and capacity of these cooling water 
intake structures reflect the best technology available for minimizing 
adverse environmental impact. EPA's rulemaking may affect existing 
facilities that use cooling water intake structures, and whose intake 
flow levels exceed a minimum threshold to be determined by EPA during 
this rulemaking. EPA will accept comments on the proposed rule until 
March 24, 2005.
 Finally, EPA is developing three rules to protect the safety of 
drinking water. First, EPA is developing a final Long Term 2 Enhanced 
Surface Water Treatment Rule (LT2ESWTR). This rule would reduce risks 
from microbial pathogens, especially Cryptosporidium, in public water 
systems that use surface water sources. LT2ESWTR provisions would 
target systems where current standards do not provide sufficient 
protection, including both filtered systems with elevated source water 
pathogen levels and unfiltered systems. Second, EPA plans to finalize 
the Ground Water Rule, a rule that addresses fecal contamination in 
public water systems served by ground water sources. Finally, EPA is 
developing a final Stage 2 Disinfectants and Disinfection Byproducts 
Rule to control exposure to disinfection byproducts beyond the 
requirements of the Stage 1 Disinfectants and Disinfection Byproducts 
Rule. This rule will respond to new data the Agency has received on: 
disinfection byproduct occurrence; bladder, colon, and rectal cancer; 
and possible reproductive and developmental health effects.
_______________________________________________________________________



EPA

                              -----------

                             PRERULE STAGE

                              -----------




115. ENDOCRINE DISRUPTOR SCREENING PROGRAM (EDSP); CHEMICAL SELECTION 
APPROACH FOR INITIAL ROUND OF SCREENING
Priority:


Other Significant


Legal Authority:


15 USC 2603 TSCA; 21 USC 346(a) FFDCA; 42 USC 300(a)(17) SDWA; 7 USC 
136 FIFRA


CFR Citation:


Not Yet Determined


Legal Deadline:


None


Abstract:


EPA published a proposed policy statement in the Federal Register 
setting forth the Endocrine Disruptor Screening Program (EDSP) on 
December 28, 1998. In that FR Notice, the Agency described the major 
elements of the Program EPA had developed to comply with the 
requirements of FFDCA section 408(p) as amended by FQPA. One of those 
elements is Priority Setting which was defined as the collection, 
evaluation, and analysis of relevant information to determine the 
general order in which chemical substances and mixtures will be 
subjected to screening and testing. Under this current action, EPA is 
developing a priority setting approach to be used by the Agency to 
identify the initial list of chemicals for which EDSP Tier 1 testing 
will be required. On December 30, 2002, EPA published in the Federal 
Register for public comment a proposed chemical selection approach for 
this initial list of chemicals. The public comment period on this 
proposed approach was extended to April 1, 2003 in a Federal Register 
notice dated February 26, 2003. EPA has considered the comments and 
will issue a Federal Register notice setting forth its final approach. 
EPA will issue an additional Federal Register notice setting forth the 
draft initial list of chemicals it proposes for testing. This 
additional notice is expected to be published to allow sufficient time 
for review and comment prior to actual Tier 1 assay testing. Although 
this action is not a rulemaking, the Agency has included it in the 
Regulatory Agenda to help inform the public.


Statement of Need:


The Endocrine Disruptor Screening Program fulfills the statutory 
requirement to screen pesticide chemicals for their potential to 
disrupt the endocrine system and adversely affect human health.


Summary of Legal Basis:


The mandate to screen pesticide chemicals for estrogenic effects that 
may affect human health is section 408(p) of the Federal Food, Drug and 
Cosmetic Act (FFDCA) (21 U.S.C. 346a(p)). Discretionary authority to 
test contaminants in sources of drinking water is in the Safe Drinking 
Water Act as amended in 1996 (42 U.S.C. 300j-17). General authority to 
require testing of chemicals and pesticides is in TSCA (15 U.S.C. 2603) 
and FIFRA (7 U.S.C. 136) respectively.


Alternatives:


A federal role is mandated under cited authority. There is no 
alternative to the role of the Federal government on this issue to 
ensure that pesticides, commercial chemicals and contaminants are 
screened and tested for endocrine disruption potential. A limited 
amount of testing may be conducted voluntarily but this will fall far 
short of the systematic screening which is necessary to protect public 
health and the environment and ensure the public that all important 
substances have been adequately evaluated.


Anticipated Cost and Benefits:


None.


Risks:


Evidence is continuing to mount that wildlife and humans may be at risk

[[Page 72825]]

from exposure to chemicals operating through an endocrine mediated 
pathway. Preliminary studies show decreases on IQ tests and increases 
in aggression in children. Severe malformations of the genitals of boys 
has increased steadily over the last two decades and fertility has 
decreased in young males. Wildlife effects have been more thoroughly 
documented. Abnormalities in birds, marine mammals, fish, amphibians, 
alligators, and shellfish have been documented in the U.S., Europe, 
Japan, Canada, and Australia which have been linked to specific 
chemical exposures. Evidence is sufficient for the U.S. to proceed on a 
two track strategy: research on the basic science regarding endocrine 
disruption and screening with validated assays to identify which 
chemicals are capable of interacting with the endocrine system. The 
combination of research and test data submitted in this program will 
enable EPA to take action to reduce risks.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Notice: Proposed67 FR 79611                                    12/30/02
Notice: Final Approach                                         04/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Additional Information:


SAN No. 4727, EDocket No. OPPT-2004-0109; Split from RIN 2070-AD26.


URL For More Information:
http://www.epa.gov/scipoly/oscpendo/prioritysetting/index.htm
Agency Contact:
Mary Belefski
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7201M
Washington, DC 20460
Phone: 202-564-8461
Fax: 202-564-8452
Email: [email protected]

Gary Timm
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7201M
Washington, DC 20460
Phone: 202-564-8474
Fax: 202 564-8482
Email: [email protected]
RIN: 2070-AD59
_______________________________________________________________________



EPA



116. NOTIFICATION OF CHEMICAL EXPORTS UNDER TSCA SECTION 12(B)
Priority:


Other Significant


Legal Authority:


15 USC 2611


CFR Citation:


40 CFR 707


Legal Deadline:


None


Abstract:


Section 12(b)(2) of the Toxic Substances Control Act (TSCA) states, in 
part, that any person who exports or intends to export to a foreign 
country a chemical substance or mixture for which submission of data is 
required under section 4 or 5(b), or for which a rule, action or order 
has been proposed or promulgated under section 5, 6, or 7, shall notify 
the EPA Administrator of such export or intent to export. The 
Administrator in turn will notify the government of the importing 
country of EPA's regulatory action with respect to the substance. 
Legislation is currently pending to address the implementation in the 
United States of the Rotterdam Convention on Prior Informed Consent 
(PIC), which itself includes export notification requirements. In order 
to address these concerns, and additional concerns expressed by other 
stakeholders, EPA has reported to OMB that as of August 2004, the PIC 
legislation is not yet in force. EPA further informed OMB that in 2005, 
the Agency will reassess the status of the legislation and, if 
appropriate, will initiate the rulemaking process for considering 
changes to the TSCA section 12(b) regulation, within the scope of 
existing statutory authority. This could include holding public 
meetings and/or issuing an ANPRM that invites interested parties to 
participate in developing amendments to the current TSCA section 12(b) 
regulations.


Statement of Need:


Industry has nominated the implementing regulations for reform 
consideration in the annual report on the costs and benefits of 
regulations, entitled ``Stimulating Smarter Regulation: 2002 Report to 
Congress on the Costs and Benefits of Regulations and Unfunded Mandates 
on State, Local, and Tribal Entities,'' that is prepared by the Office 
of Management and Budget (OMB) and submitted to Congress each year. 
(See OMB's compilation of comments, summary no. 190, pg 10, commenter 
no. 12 available at http://www.whitehouse.gov/omb/inforeg/key--
comments.html.)


Summary of Legal Basis:


Section 12(b)(2) of the Toxic Substances Control Act (TSCA).


Alternatives:


To be determined.


Anticipated Cost and Benefits:


Minimal, but yet to be determined.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Notice                                                         08/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


None


Additional Information:


SAN 4858.

[[Page 72826]]

Agency Contact:
Greg Schweer
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7405M
Washington, DC 20460
Phone: 202-564-8469
Fax: 202 564-4765
Email: [email protected]

David Williams
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7405M
Washington, DC 20460
Phone: 202 564-8179
Fax: 202 564-4765
Email: [email protected]
RIN: 2070-AJ01
_______________________________________________________________________



EPA



117. LEAD-BASED PAINT ACTIVITIES; VOLUNTARY PROGRAM FOR RENOVATION AND 
REMODELING
Priority:


Other Significant


Legal Authority:


15 USC 2682 TSCA 4 402; PL 102-550 sec 402(c)(3)


CFR Citation:


40 CFR 745


Legal Deadline:


None


Abstract:


As an alternative to the regulatory program, EPA is working with 
stakeholders to develop a voluntary program for renovations and 
remodeling activities. The voluntary program would partner the Agency 
and national organizations together to promote an initiative which 
could provide incentives to participating contractors and property 
owners who incorporate lead safe work practices into their standard 
operating procedures. The Agency plans, in a Notice or ANPRM to be 
published in the winter of 2004, to introduce the voluntary program, 
discuss its component parts, and review how it will be evaluated.


Statement of Need:


Childhood lead poisoning is a pervasive problem in the United States, 
with almost a million young children having more than 10 ug/dl of lead 
in their blood, (Center for Disease Control's level of concern). 
Although there have been dramatic declines in blood-lead levels due to 
reductions of lead in paint, gasoline, and food sources, remaining 
paint in older houses continues to be a significant source of childhood 
lead poisoning. These rules will help insure that individuals and firms 
conducting lead-based paint activities will do so in a way that 
safeguards the environment and protects the health of building 
occupants, especially children under 6 years old.


Summary of Legal Basis:


TSCA section 402(c) directs EPA to address renovation and remodeling 
activities by first conducting a study of the extent to which persons 
engaged in various types of renovation and remodeling activities are 
exposed to lead in the conduct of such activities or disturb lead and 
create a lead-based paint hazard on a regular basis. Section 402(c) 
further directs the Agency to revise the lead-based paint activities 
regulations (40 CFR part 745 subpart L) to include renovation or 
remodeling activities that create lead-based paint hazards. In order to 
determine which contractors are engaged in such activities the Agency 
is directed to utilize the results of the study and consult with the 
representatives of labor organizations, lead-based paint activities 
contractors, persons engaged in remodeling and renovation, experts in 
health effects, and others.


Alternatives:


TSCA section 402(c) states that should the Administrator determine that 
any category of contractors engaged in renovation or remodeling does 
not require certification; the Administrator may publish an explanation 
of the basis for that determination. This voluntary program is one of 
the key alternatives considered to developing a more prescriptive 
regulatory program.


Anticipated Cost and Benefits:


EPA's quantitative cost estimates fall into four categories: Training 
Costs, Work Practice Costs, Clearance Testing Costs, and Administrative 
Costs. The estimates vary depending upon the option selected. In most 
cases we expect that requirements related to Clearance Testing and Work 
Practices will contribute the most to overall rule cost. The benefits 
analysis will not provide direct quantitative measures of each (or any) 
option. EPA does not have a complete risk assessment (with dose-
response functions) that would permit direct quantitative estimates. We 
do have other data, such as estimated loadings of Pb generated by 
renovation work, number and type of renovation events, demographics of 
the exposed population, and the costs of various health effects 
previously linked to Pb exposure. With the available information we are 
able to utilize several qualitative approaches to frame the benefits 
associated with an effective renovation rule.


Risks:


Like the rules under consideration, this voluntary program is aimed at 
reducing the prevalence and severity of lead poisoning, particularly in 
children. The Agency has concluded that many R&R work activities can 
produce or release large quantities of lead and may be associated with 
elevated blood lead levels. These activities include, but are not 
limited to: sanding, cutting, window replacement, and demolition. Lead 
exposure of R&R workers appears to be less of a problem than that of 
building occupants (especially young children). Some workers (and 
homeowners) are occasionally exposed to high levels of lead. Any work 
activity that produces dust and debris may create a lead exposure 
problem.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Notice Announcing 1st Pilot                                    12/00/04
Notice Announcing 2nd Pilot                                    05/00/05
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Federal, Local, State, Tribal


Additional Information:


SAN No. 3557.1; Split from RIN 2070-AC83.

[[Page 72827]]

Agency Contact:
Mike Wilson
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7404T
Washington, DC 20460
Phone: 202-566-0521
Fax: 202 566-0469
Email: [email protected]

Julie Simpson
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7404T
Washington, DC 20460
Phone: 202-566-1980
Fax: 202 566-0471
Email: [email protected]
RIN: 2070-AJ03
_______________________________________________________________________



EPA

                              -----------

                          PROPOSED RULE STAGE

                              -----------




118. CLEAN AIR FINE PARTICLE IMPLEMENTATION RULE
Priority:


Other Significant


Unfunded Mandates:


This action may affect State, local or tribal governments and the 
private sector.


Legal Authority:


42 USC 7410; 42 USC 7501 et seq


CFR Citation:


40 CFR 51


Legal Deadline:


None


Abstract:


In 1997, EPA promulgated revised National Ambient Air Quality Standards 
(NAAQS) for fine particulate matter (PM-2.5). The rule described in 
this paragraph--the Implementation Rule for PM-2.5 NAAQS--will include 
requirements and guidance for State and local air pollution agencies to 
develop and submit State implementation plans (SIPs) designed to bring 
the areas into attainment with the 1997 standards. These SIP-
development activities include conducting technical analyses to 
identify effective strategies for reducing emissions contributing to 
PM-2.5 levels, and adopting regulations as needed in order to attain 
the standards. Ambient air quality monitoring for 1999-2001 shows that 
areas exceeding the standards are located throughout the eastern half 
of the United States and in California. Estimates show that compliance 
with the standards will prevent thousands of premature deaths from 
heart and lung disease, tens of thousands of hospital admissions and 
emergency room visits, and millions of absences from school and work 
every year.


Statement of Need:


This rule is needed in order to provide guidance to State and local 
agencies in preparing State Implementation Plans (SIPs) designed to 
bring areas into attainment with the 1997 PM-2.5 standards. The 
implementation requirements for nonattainment areas are generally 
described in subpart 1 of section 172 of the Clean Air Act. This rule 
provides further interpretation of those requirements for the PM-2.5 
standards.


Summary of Legal Basis:


42 USC 7410 and 42 USC 7501 et seq.


Alternatives:


Alternatives will be explored as the proposal is developed.


Anticipated Cost and Benefits:


This information will be provided as the proposal is developed.


Risks:


The risks addressed by this rule are those addressed by the 1997 NAAQS 
rule -- i.e., the health and environmental risks associated with 
nonattainment of the NAAQS. These risks were summarized in detail in 
the analyses accompanying the 1997 NAAQS rule.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           11/00/04
Final Action                                                   06/00/05
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


Federal, Local, State, Tribal


Additional Information:


SAN No. 4752;


Agency Contact:
Rich Damberg
Environmental Protection Agency
Air and Radiation
C504-02
Washington, DC 20460
Phone: 919-541-5592
Fax: 919 541-5489
Email: [email protected]

Joe Paisie
Environmental Protection Agency
Air and Radiation
C504-02
Research Triangle Park, NC 27711
Phone: 919-541-5556
Fax: 919 541-5489
Email: [email protected]
RIN: 2060-AK74
_______________________________________________________________________



EPA



119. PREVENTION OF SIGNIFICANT DETERIORATION (PSD) AND NONATTAINMENT 
NEW SOURCE REVIEW (NSR): ALLOWABLES PLANTWIDE APPLICABILITY LIMIT 
(PAL), AGGREGATION, AND DEBOTTLENECKING
Priority:


Other Significant


Legal Authority:


42 USC 7401 et seq


CFR Citation:


40 CFR 51.165; 40 CFR 51.166; 40 CFR 52.21


Legal Deadline:


None


Abstract:


These rules clarify when less than significant emissions increases from 
multiple activities at a single major stationary source must be 
considered together for the purposes of determining major new source 
review (NSR) applicability (aggregation). We are also changing in the 
way emissions from permitted emissions units upstream or downstream 
from those undergoing a physical change or change in the method of 
operation are considered when determining if a proposed project will 
result in a significant emissions increase (debottlenecking). The rules 
also provide an allowables plantwide applicability limit (PAL) option 
that is based on the allowable emissions from major stationary sources. 
A PAL is an optional approach that provides the owners or operators of 
major stationary sources with the ability to manage

[[Page 72828]]

facility-wide emissions without triggering major NSR. The added 
flexibility of a PAL allows sources to respond rapidly to market 
changes consistent with the goals of the NSR program. The regulations 
for aggregation and debottlenecking are intended to improve 
implementation of the program by articulating principles for 
determining major NSR applicability that were previously addressed 
through guidance only. The purpose of the allowables PAL rule is to 
encourage major stationary sources to install state-of-the-art controls 
in exchange for regulatory certainty and flexibility.


Statement of Need:


The current New Source Review program provides for emissions from 
multiple projects to be aggregated (aggregation) as one single project 
under certain circumstances. Similarly, when making a PSD applicability 
calculation, emissions from units whose effective capacity and 
potential to emit have been increased as a result of a modification to 
another unit (debottlenecked units), must be included in the initial 
PSD applicability calculations. Specific questions regarding the 
application of these two terms have been addressed on a case-by-case 
basis. By completing this rulemaking, regulated entities and regulatory 
agencies will be provided an additional level of certainty in 
addressing applicability issues. In December 2002 we promulgated NSR 
rules for a Plantwide Applicability Limit (PAL) based on actual 
emissions that applies to existing major stationary sources. In 2005, 
we will propose an allowables PAL based on a facility's allowable 
emissions mainly for greenfield sources. If a company commits to keep 
its facility emissions below Allowables PAL level, then these 
regulations will allow the plant owners to avoid the NSR permitting 
process when they make changes at individual units at the plant, as 
long as the total emissions from the facility will not increase. This 
would provide flexibility for sources to respond rapidly to market 
changes without compromising environmental protection.


Summary of Legal Basis:


42 USC 7411(a)(4)


Alternatives:


Alternatives will be developed as the rulemaking proceeds.


Anticipated Cost and Benefits:


Cost and benefit information will be developed as appropriate as the 
rulemaking proceeds.


Risks:


Risk information will be developed as appropriate as the rulemaking 
proceeds.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           02/00/05
Final Action                                                   10/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, Local, State, Tribal


Additional Information:


SAN No. 4793;


Agency Contact:
Juan Santiago
Environmental Protection Agency
Air and Radiation
C33903
Washington, DC 20460
Phone: 919-541-1084
Fax: 919 541-5509
Email: [email protected]

Raj Rao
Environmental Protection Agency
Air and Radiation
C339-03
Washington, DC 20460
Phone: 919-541-5344
Fax: 919 541-5509
Email: [email protected]
RIN: 2060-AL75
_______________________________________________________________________



EPA



120. PESTICIDES; DATA REQUIREMENTS FOR CONVENTIONAL CHEMICALS
Priority:


Other Significant


Legal Authority:


7 USC 136(a) to 136(y)


CFR Citation:


40 CFR 158


Legal Deadline:


None


Abstract:


EPA will propose revisions to its data requirements for the 
registration of conventional pesticide products. In this action, the 
Agency will propose revisions to the data requirements that pertain to 
product chemistry, toxicology, residue chemistry, applicator exposure, 
post-application exposure, nontarget terrestrial and aquatic organisms, 
nontarget plant protection, and environmental fate. The proposed data 
requirements will reflect current scientific knowledge and 
understanding. These revisions would improve the Agency's ability to 
make regulatory decisions about the human health and environmental 
effects of pesticide products to better protect wildlife, the 
environment, and people, including sensitive subpopulations. Coupled 
with revision of data requirements, EPA will propose to reformat the 
requirements and revise its general procedures and policies associated 
with data submission. By codifying existing data requirements which are 
currently applied on a case-by-case basis, the pesticide industry, 
along with other partners in the regulated community, would attain a 
better understanding and could better prepare for the pesticide 
registration process. EPA intends to propose a series of revisions to 
the data requirements, covering different data disciplines and product 
types.


Statement of Need:


Since the data requirements were first published in 1984, the 
information needed to support the registration of a pesticide has 
evolved along with the expanding knowledge base of pesticide chemical 
technology. Over the years, updated data requirements have been applied 
on a case-by-case basis to support individual registration applications 
or imposed by data call-in on registrants of similar products. The 
codified data requirements have not been revised to keep pace with the 
updated data requirements. EPA will also propose to reformat the data 
requirements and revise procedures and policies for data submission. 
The changes to be proposed are intended to provide stakeholders with a 
more transparent and improved clarity of the potential data 
requirements, more focused use patterns that reflect current practice, 
and a more efficient registration process.


Summary of Legal Basis:


The planned proposed rule is intended to describe data and information 
needed to support multiple pesticide mandates under two statutes, 
specifically the registration, reregistration, registration review,

[[Page 72829]]

experimental use permit programs under the Federal Insecticide, 
Fungicide and Rodenticide Act (FIFRA), and the tolerance-setting 
program under the Federal Food, Drug and Cosmetic Act (FFDCA). FIFRA 
section 3(c) requires that applicants for registration provide the 
Agency a full description of tests made and the results that support 
the registration of a pesticide product, and requires the Agency to 
issue guidelines specifying the kinds of information needed to support 
registration. FIFRA section 3(g) requires the Agency to review every 15 
years the registration of each pesticide, and determine that it 
continues to meet the registration standard. The data requirements 
established for registration will be the foundation of the Agency's 
registration review. FIFRA section 4 requires the Agency to reregister 
pesticides that were registered prior to 1984, and in so doing, to 
provide data and summaries of studies previously submitted to support 
registration. FIFRA section 5 authorizes the Agency to issue 
experimental use permits for which data may be required. FFDCA section 
408 authorizes EPA to establish tolerances (or expemptions from 
tolerance) for pesticide residues in food, and prescribes generally the 
types of data that are to be submitted to support such tolerances.


Alternatives:


The Agency is required by its various statutory mandates to establish 
data requirements that support its regulatory decisions. It is 
incumbent on the Agency to reevaluate those data requirements in light 
of scientific advances, analytical improvements, and new technology, in 
order to provide a sound scientific basis for those decisions. 
Accordingly, EPA sees no alternative to the overall need to update and 
revise its data requirements periodically. As it does so, however, each 
individual data requirement is evaluated against current scientific 
standards, value and cost, and undergoes an extensive review, including 
external and public participation, to assess the continued need for the 
data. The Agency also considers whether alternative regulatory methods, 
such as restrictions on use, would obviate the need for data, and 
explores means of introducing flexibility and clarity to reduce burdens 
on the regulated community.


Anticipated Cost and Benefits:


Although estimates may change before the proposal is published, the 
following estimates are based on the current draft Economic Analysis. 
Using the currently codified requirements as the baseline for the 
impact analysis, the total annual impact of the proposed revisions to 
the pesticide industry is estimated to be about $50 million. Of this 
estimated total annual impact, about $29 million per year represents 
new data requirements that were imposed over the years but were not 
specified in the existing CFR. As they have been applied to an 
increasing number of registrations, these data requirements have become 
more regularly required and will be proposed for codification. In 
addition, about $22 million represents the cost of the proposed 
modified or expanded existing data requirements for certain tests and 
use patterns, and about $2 million represents the cost of proposed new 
data requirements for data that have not yet been routinely sought. The 
benefits are difficult to quantify but were an important part of the 
Agency consideration in developing the proposal. The following parties 
are expected to benefit: consumers and the general public; farmers and 
other workers; registrants; animal welfare concerns; scientific, 
environmental and health communities; State and local governments; EPA 
and other Federal agencies; and governments outside the United states.


Risks:


The revisions to the data requirements to be proposed, like the 
existing requirements in part 158, would require an applicant for 
pesticide registration to supply the Agency with information on the 
pesticide: composition, toxicity, potential human exposure, 
environmental properties and ecological effects, and efficacy in 
certain cases. This information is used to assess the human health and 
environmental risks associated with the product. The data that would be 
required by this regulation in its current form, and as expected to be 
proposed, form the foundation of EPA's risk assessment for pesticides, 
and provide a sound scientific basis for any licensing decisions that 
impose requirements that mitigate or reduce risks, and that ensure that 
pesticide residues in food meet the ``reasonable certainty of no harm'' 
risk standard of the FFDCA.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           01/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


Federal


Additional Information:


SAN 2687.


Sectors Affected:


32532 Pesticide and Other Agricultural Chemical Manufacturing


Agency Contact:
Melissa Chun
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7506C
Washington, DC 20460
Phone: 703-305-4027
Fax: 703 305-5884
Email: [email protected]

Jean Frane
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7506C
Washington, DC 20460
Phone: 703-305-5944
Fax: 703 305-5884
Email: [email protected]
RIN: 2070-AC12
_______________________________________________________________________



EPA



121. PESTICIDES; EMERGENCY EXEMPTION PROCESS REVISIONS
Priority:


Other Significant


Legal Authority:


7 USC 136p; 7 USC 136w


CFR Citation:


40 CFR 166


Legal Deadline:


None


Abstract:


EPA will publish a Notice of Proposed Rulemaking in the Federal 
Register proposing several improvements to the pesticide emergency 
exemption process under section 18 of the Federal Insecticide, 
Fungicide, and Rodenticide

[[Page 72830]]

Act (FIFRA). Two of these potential improvements are currently being 
tested through a limited pilot, and are based on recommendations from 
the States which are the primary applicants for emergency exemptions. 
EPA has established regulations under section 18 of FIFRA which allow a 
Federal or State agency to apply for an emergency exemption to allow an 
unregistered use of a pesticide for a limited time when such use is 
necessary to alleviate an emergency condition. The proposed revisions 
would streamline the application and review process, thereby reducing 
the burden to applicants and EPA, while allowing for quicker emergency 
response without compromising existing protections for human health and 
the environment.


Statement of Need:


In 1996, stakeholders, including States and Federal agencies, 
identified a number of issues related to improving the emergency 
exemption process. States and Federal agencies are the only applicants 
for emergency exemptions. Representatives of States have recommended 
modifications to the current process for application, review and 
approval of emergency exemptions. If adopted, the changes would reduce 
unnecessary burden to both applicants and EPA, and expedite decisions 
on applications (which is critical in emergency situations).


Summary of Legal Basis:


FIFRA section 18 authorizes EPA to temporarily exempt States from the 
requirements of registration to alleviate an emergency condition.


Alternatives:


EPA has analyzed several measures for streamlining or improving the 
emergency exemption process, and has received considerable comment, 
both formally and informally, from stakeholders, including specific 
recommendations from a group representing States' interests. Since the 
modifications would generally constitute regulatory relief, and are not 
expected to cause any adverse economic impact, options with varying 
cost do not apply.


Anticipated Cost and Benefits:


EPA has assessed the potential economic impacts of the proposed 
improvements and found that they would reduce burdens and costs to 
States and Federal agencies that apply for emergency exemptions, as 
well as reduced burden to EPA. The Agency estimates an annual cost 
reduction of $820,000 for applicants and $120,000 for EPA, for a total 
of $940,000. Indirect benefits may accrue to users of pesticides under 
emergency exemptions if changes result in faster review and approval, 
or greater availability of pesticides.


Risks:


In general, the measures being considered are primarily intended to 
reduce burdens for States and EPA and achieve efficiencies in the 
program. No impact on risk is anticipated.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Notice: Limited 68 FR 20145                                    04/24/03
NPRM            69 FR 53866                                    09/03/04
NPRM Comment Period End                                        11/02/04
Final Action                                                   03/00/06
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, State


Additional Information:


SAN No. 4216, EDocket No. OPP-2004-0038;


Sectors Affected:


9241 Administration of Environmental Quality Programs


Agency Contact:
Joe Hogue
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7506C
Washington, DC 20460
Phone: 703-308-9072
Fax: 703 305-5884
Email: [email protected]

Jean Frane
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7506C
Washington, DC 20460
Phone: 703-305-5944
Fax: 703 305-5884
Email: [email protected]
RIN: 2070-AD36
_______________________________________________________________________



EPA



122. ACCEPTABILITY OF RESEARCH USING HUMAN SUBJECTS
Priority:


Other Significant


Legal Authority:


5 USC 301; 7 USC 136a; 7 USC 136w; 15 USC 2603; 21 USC 346a; 42 USC 
300v-1(b); 42 USC 7601; 33 USC 1361; 42 USC 9615; 42 USC 11048; 42 USC 
6912; 42 USC 300j-9


CFR Citation:


40 CFR 26 (Revision)


Legal Deadline:


None


Abstract:


EPA is evaluating its current policy with respect to the protection of 
human research subjects in testing. Current EPA regulations in 40 CFR 
part 26 apply to research conducted or supported by the Agency or 
``otherwise subject to regulation.'' No action has been taken yet to 
give effect to the ``otherwise subject to regulation'' phrase. In 
addition, EPA has received the advice of the National Academy of 
Sciences (NAS) on several issues surrounding the acceptability and 
interpretation of third party studies involving deliberate dosing of 
human subjects for the purpose of defining or quantifying toxic 
endpoints and public comment on an ANPRM. EPA will seek public comment 
on issues related to Agency use of human research data in its 
regulatory decisionmaking. EPA believes the process being initiated 
will serve two important Agency goals: ensuring the availability of 
sound and appropriate scientific data in its decisions, and protection 
of the interests, rights and safety of human research subjects. EPA may 
issue one or more documents, which may include policy statements, 
rulemaking or requests for public comment.


Statement of Need:


In July 1998, the Agency stated that it had not used any human study 
data for final decisions under the FQPA. The Agency subsequently 
convened a special joint subcommittee of the FIFRA Scientific Advisory 
Panel and the EPA Science Advisory Board to advise on this policy. The 
subcommittee completed its report in September 2000 without reaching 
consensus on many issues. In December 2001 the Agency sought the advice 
of the National Academy of Sciences on remaining scientific and ethical 
issues.

[[Page 72831]]

 At the same time, the Agency clarified its interim policy, committing, 
subject to certain exceptions, not to consider or rely on any third 
party studies involving intentional dosing of human subjects with 
toxicants for the purpose of defining or quantifying their effects 
until a final policy is in place, and clarifying that this interim 
policy applies across all Agency programs. In May 2003 the Agency 
published an Advance Notice of Proposed Rulemaking on the subject of 
the acceptability of human studies, posing an array of questions in 
response to which many comments and suggestions were received. The 
ANPRM also restated the Agency's intention to issue proposed rules for 
comment. In June 2003, the U.S. Court of Appeals vacated the December 
2001 interim policy on the ground that it constituted an improperly 
promulgated ``rule.'' The court further stated that as a consequence 
the Agency's ``previous practice of considering third party human 
studies on a case-by-case basis, applying statutory requirements, the 
Common Rule, and high ethical standards as a guide,`` was reinstated 
''until it is replaced by a lawfully promulgated regulation.`` In 
February 2004, the NAS released their report, making many 
recommendations now under review by the Agency. Some of the Academy's 
recommendations could only be implemented through rulemaking.


Summary of Legal Basis:


Rulemaking concerning human studies is authorized under a variety of 
provision of the different environmental statutes EPA administers. With 
respect to pesticides, the Federal Insecticide, Fungicide and 
Rodenticide Act (7 U.S.C. 136), a licensing statute, requires 
applicants for registration to provide a ``full description of tests 
made and the results thereof'' and further authorizes EPA to call in 
data to maintain a registration under FIFRA sec. 3(c)(2)(B). FIFRA sec. 
25(a) provides general rulemaking authority to implement these data 
requirements, and also to interpret FIFRA sec. 12(a)(2)(P), which makes 
it unlawful to conduct tests using human subjects unless the subjects 
volunteer for such tests and are fully informed. Section 408(e) of the 
Federal Food, Drug and Cosmetic Act (21 U.S.C. 348) authorizes the 
Administrator to issue regulations establishing general procedures and 
requirements. The Clean Air Act (42 U.S.C. 7601(a)) gives EPA general 
rulemaking authority. The Clean Water Act (33 U.S.C. 1361) authorizes 
the Administrator to promulgate regulations. The Comprehensive 
Environmental Response, Compensation, and Liability Act (42. U.S.C. 
9615) authorizes the President to establish regulations to implement 
the statute, this authorizes being delegated to the Administrator under 
Executive Order 12580. The Emergency Planning and Community Right-to-
Know Act (42. U.S.C. 11048) contains a general rulemaking authority. 
The Resource Conservation and Recovery Act (42 U.S.C. 6912) 
specifically authorizes the Administrator to prescribe regulations to 
carry out the functions under the Act. The Safe Drinking Water Act (42 
U.S.C. 300j-9) authorizes the Administrator to prescribe regulations 
that are necessary and appropriate to carry out EPA's functions under 
the Act. In addition, EPA has broad authority under 5 U.S.C. 301 and 42 
U.S.C. 300v-1(b).


Alternatives:


Still to be identified.


Anticipated Cost and Benefits:


No analysis has been performed yet.


Risks:


No analysis has been performed yet.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           68 FR 24410                                    05/07/03
Notice                                                         01/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal


Additional Information:


SAN No. 4610, EDocket No. OPP-2003-0132;


Sectors Affected:


32532 Pesticide and Other Agricultural Chemical Manufacturing


Agency Contact:
William Jordan
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7501C
Washington, DC 20460
Phone: 703-305-1049
Fax: 703-308-4776
Email: [email protected]

John Carley
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7501C
Washington
Phone: 703-305-7019
Fax: 703-305-5060
Email: [email protected]
RIN: 2070-AD57
_______________________________________________________________________



EPA



123. INCREASE METALS RECLAMATION FROM F006 WASTE STREAMS
Priority:


Other Significant


Unfunded Mandates:


Undetermined


Legal Authority:


Not Yet Determined


CFR Citation:


40 CFR 261


Legal Deadline:


None


Abstract:


Many metal finishers and other industrial sectors generate an 
electroplating sludge as part of their production process that is 
amenable to recycling, i.e., the sludge contains economically 
recoverable amounts of metals such as copper, nickel, zinc, etc. 
Currently, these sludges (F006) are listed hazardous wastes subject to 
RCRA regulations. Many generators continue to send these sludges for 
treatment and disposal when they could be recycled. Similarly, 
generators currently sending their sludges for recycling receive no 
economic benefit for this practice. Since the mid-1990s, EPA has been 
working with industry and the States to create incentives for safe 
recycling and has promulgated rules to foster this practice. However, 
EPA is interested in exploring whether further regulatory changes are 
warranted.

[[Page 72832]]

EPA is currently evaluating several options that would provide 
regulatory relief to generators and handlers of F006. All options would 
reduce regulatory costs to generators and handlers relative to the 
current RCRA subtitle C regulatory program.


Statement of Need:


F006 represents one of the largest hazardous waste streams amenable to 
recycling. Currently, there is no differentiation in regulatory 
requirements between the land disposal and recycling of F006 
electroplating sludges. This effort seeks to evaluate different 
regulatory options that would eliminate existing disincentives to the 
safe recycling of F006 with the ultimate objective of possibly 
proposing changes to the existing regulatory framework. Potential 
benefits to be achieved include increasing the economic competitiveness 
of small businesses, increasing the waste minimization and recycling of 
F006, and increasing natural resource conservation by reducing 
emissions from landfills and surface waters.


Summary of Legal Basis:


RCRA sections 2002, 3001-3004, 42 U.S.C. 6912, 6921-6924. No aspect of 
this action is required by statute or court order.


Alternatives:


Regulatory options being examined would affect generators and possibly 
other handlers of F006, i.e., consolidators, commercial hazardous waste 
recyclers and mineral processing facilities. EPA is also considering 
various options for the minimum amount of recoverable metals contained 
in F006 electroplating sludges.


Anticipated Cost and Benefits:


This rule is designed to provide regulatory relief to generators and 
possibly other handlers of F006. Potential benefits to be achieved 
include increasing the economic competitiveness of small businesses, 
increasing the waste minimization and recycling of F006 and increasing 
natural resource conservation by reducing emissions from landfills and 
surface waters.


Risks:


Options being evaluated would ensure that the risks posed from 
recycling F006 would not increase. These include risks from storage and 
management of the materials throughout the recycling process, as well 
risks from any non-recyclable constituents included in the F006.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           09/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Additional Information:


SAN No. 4651


Agency Contact:
Jim OLeary
Environmental Protection Agency
Solid Waste and Emergency Response
5304W
Washington, DC 20460
Phone: 703-308-8827
Fax: 703 308-0514
Email: [email protected]

James Michael
Environmental Protection Agency
Solid Waste and Emergency Response
5304W
Washington, DC 20460
Phone: 703-308-8610
Fax: 703 308-0514
Email: [email protected]
RIN: 2050-AE97
_______________________________________________________________________



EPA



124. REGULATORY AMENDMENTS TO THE F019 HAZARDOUS WASTE LISTING TO 
EXCLUDE WASTEWATER TREATMENT SLUDGES FROM CHEMICAL CONVERSION COATING 
PROCESS (ZINC PHOSPHATING) OF AUTOMOBILE BODIES OF ALUMINUM
Priority:


Other Significant


Unfunded Mandates:


Undetermined


Legal Authority:


42 USC 1006 et seq


CFR Citation:


40 CFR 261.31; 40 CFR 302.4


Legal Deadline:


None


Abstract:


Automobile manufacturers are adding aluminum or aluminized components 
to automobiles to reduce the weight of vehicles to increase fuel 
economy. When aluminum components are added to the automobile assembly 
process, the current Federal regulations require that the wastewater 
treatment sludges generated from this conversion coating process be 
managed as a hazardous waste under the Resource Conservation and 
Recovery Act. EPA intends to reduce burden on the regulated community 
by revising the current RCRA regulations that apply to the wastewater 
treatment sludges from the chemical conversion coating (zinc 
phosphating) of aluminum.


Statement of Need:


This action when finalized will reduce the burden on the automobile 
industry from treating sludges from the process of zinc phosphating of 
aluminum as hazardous wastes. The applicable listed hazardous waste 
(F019) was listed as such because it contains cyanide and chromium. The 
sludges from the zinc phosphating of aluminum do not contain any of 
these constituents.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           11/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Undetermined


Additional Information:


SAN No. 4834;


Agency Contact:
James Michael
Environmental Protection Agency
Solid Waste and Emergency Response
5304W
Washington, DC 20460
Phone: 703-308-8610
Fax: 703 308-0514
Email: [email protected]

Gail Cooper
Environmental Protection Agency
Solid Waste and Emergency Response
5304W
Washington, DC 20460
Phone: 703 308-8419
Fax: 703 308-0514
Email: [email protected]
RIN: 2050-AG15

[[Page 72833]]

_______________________________________________________________________



EPA



125. TOXICS RELEASE INVENTORY REPORTING BURDEN REDUCTION RULE
Priority:


Other Significant


Legal Authority:


42 USC 11023 et seq


CFR Citation:


40 CFR 372


Legal Deadline:


None


Abstract:


The primary goal of this effort by EPA is to reduce burdens associated 
with Toxics Release Inventory (TRI) reporting while at the same time 
continuing to provide valuable information to the public consistent 
with the goals and statutory requirements of the TRI program.


Statement of Need:


EPA is looking to explore various options with the intention of 
identifying a specific burden reduction initiative that effectively 
lessens the burden on facilities but at the same time ensures that TRI 
continues to provide communities with the same high level of 
significant chemical release and other waste management information.


Summary of Legal Basis:


Section 313 of the Emergency Planning and Community Right-to-Know Act 
(EPCRA) of 1986 and section 6607 of the Pollution Prevention Act (PPA) 
of 1990.


Alternatives:


Still under analysis.


Anticipated Cost and Benefits:


Still under analysis.


Risks:


Not applicable.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           01/00/05
Final Action                                                   02/00/07
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, State


Additional Information:


SAN No. 4896;


URL For More Information:
www.epa.gov/tri
Agency Contact:
Cassandra Vail
Environmental Protection Agency
Office of Environmental Information
2844T
Washington, DC 20460
Phone: 202-566-0753
Fax: 202 566-0741
Email: [email protected]

Kevin Donovan
Environmental Protection Agency
Office of Environmental Information
2844T
Washington, DC 20460
Phone: 202-566-0676
Fax: 202-566-0715
Email: [email protected]
RIN: 2025-AA14
_______________________________________________________________________



EPA

                              -----------

                            FINAL RULE STAGE

                              -----------




126. CLEAN AIR VISIBILITY RULE
Priority:


Economically Significant


Legal Authority:


42 USC 7410; 42 USC 7414; 42 USC 7421; 42 USC 7470 to 7479; 42 USC 
7491; 42 USC 7492; 42 USC 7601; 42 USC 7602


CFR Citation:


40 CFR 51.308(e)(1); 40 CFR 51 app Y (New)


Legal Deadline:


NPRM, Judicial, April 15, 2004, Consent Decree: April 15, 2004.


Final, Judicial, April 15, 2005, Consent Decree: April 15, 2005.


Abstract:


To meet the Clean Air Act's requirements, EPA published the regional 
haze rule on July 1, 1999 (64 FR 35714). On May 24, 2002, the DC 
Circuit vacated certain provisions of the regional haze rule related to 
best available retrofit technology (BART). Because of this court 
decision, we need to propose and publish revised BART provisions in the 
regional haze rule. The purpose of this effort is to provide the 
appropriate changes to the BART requirements and guidelines, and to 
address additional issues related to reasonable progress goals for the 
visibility program. On July 20, 2001, we proposed guidelines intended 
to add further clarifications to the BART requirements in the regional 
haze rule. Since then, due to additional information that has come to 
light since that proposal, we have decided that a supplemental proposal 
is needed. The supplemental proposal was published on May 5, 2004.


Statement of Need:


This action is needed in response to the May 2002 ruling of the U.S. 
Court of Appeals for the D.C. Circuit (American Corn Growers et al. V. 
EPA,, 291 F.3d 1) vacating the Best Available Retrofit Technology 
(BART) provisions of the regional haze rule. The Clean Air Act requires 
that States to include BART in their visibility State Implementation 
Plans (SIPs). The Clean Air Act also requires that a State take steps 
to prevent emissions from sources located within its boundaries from 
interfering with a downwind State's ability to meet air quality 
standards, or interfering with measures to protect visibility.


Summary of Legal Basis:


Clean Air Act section 169A requires States to include BART in their 
visibility SIPs. Clean Air Act section 110(a)(2)(D) (42 USC 
7410(a)(2)(D)) requires that each state's implementation plan include 
the ``good neighbor'' provisions of prohibiting sources in the State 
from emitting air pollutants in amounts that contribute significantly 
to nonattainment in a downwind state, or interfere with measures to 
protect visibility in a Class I areas. Section 110(a)(1) (42 USC 
7410(a)(1)) requires States to submit implementation plans within a 
specified period of time after the promulgation of a new or revised 
national ambient air quality standard. In addition, EPA has authority 
under section 110(k)(5) (42 USC 7410(k)(5)) to require States to revise 
existing implementation plans whenever EPA finds that those plans are 
inadequate to comply with any requirement. Further, section 301(a)(1) 
(42 USC 7601(a)(1)) confers general authority upon the EPA 
Administrator. These provisions of the Clean Air Act confer authority 
on EPA to promulgate the present regulations.


Alternatives:


This entry comprises the action the Agency plans to take to implement 
the

[[Page 72834]]

BART provisions of the Clean Air Act. The major alternatives facing the 
Agency include: (1) How to structure the process for exempting 
individual emission sources from BART that is mandated by the court 
ruling, and (2) whether to include prescriptive control levels for 
visibility-impairing pollution from large electric generating units, 
and what control levels to prescribe.


Anticipated Cost and Benefits:


EPA prepared a regulatory impact analysis (RIA) for the proposed BART 
rule. Updated cost and benefit calculations will be made as development 
of the RIA proceeds for the final rulemaking.


Risks:


The risks addressed are the health and welfare impacts resulting from 
emissions that interfere with measures to protect visibility in Class I 
areas. These effects were outlined in detail in the Regulatory Impact 
Analysis for the proposed BART rulemaking.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            66 FR 38108                                    07/20/01
Supplemental NPR69 FR 25184                                    05/05/04
Final Action                                                   04/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, Local, State, Tribal


Federalism:


 Undetermined


Additional Information:


SAN No. 4450;


Agency Contact:
Kathy Kaufman
Environmental Protection Agency
Air and Radiation
C504-02
Washington, DC 20460
Phone: 919-541-0102
Fax: 919 541-5489
Email: [email protected]

Todd Hawes
Environmental Protection Agency
Air and Radiation
C504-02
Washington, DC 20460
Phone: 919-541-5591
Fax: 919 541-5489
Email: [email protected]
RIN: 2060-AJ31
_______________________________________________________________________



EPA



127. CLEAN AIR MERCURY RULE--ELECTRIC UTILITY STEAM GENERATING UNITS
Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


This action may affect State, local or tribal governments and the 
private sector.


Legal Authority:


42 USC 7412; 42 USC 7411


CFR Citation:


40 CFR 63; 40 CFR 60


Legal Deadline:


NPRM, Judicial, December 15, 2003.


Final, Judicial, March 15, 2005.


Abstract:


On January 30, 2004, the EPA proposed alternative approaches to 
regulating mercury emissions from coal-fired electric utility steam 
generating units and nickel emissions from oil-fired electric utility 
steam generating units.


Statement of Need:


Oil and coal-fired electric utility steam generating units were added 
(December 20, 2000) to the list of source categories to be regulated 
under section 112 of the Clean Air Act, as amended. On January 30, 
2004, EPA proposed to remove oil- and coal-fired electric utility steam 
generating units from the list so that they could be regulated under 
section 111 of the Clean Air Act.


Summary of Legal Basis:


Sections 111 and 112 of the Clean Air Act, as amended.


Alternatives:


Alternative approaches to regulating electric utility steam generating 
units were proposed on January 30, 2004.


Anticipated Cost and Benefits:


It is anticipated that this rule will result in significant costs to 
the affected industry, including Federal, State, and local entities 
that own/operate electric utility steam generating units. These costs 
will be identified as the final rule is developed.


Risks:


Risk information will become available as the final rule is developed.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            69 FR 4754                                     01/30/04
Supplemental NPR69 FR 12298                                    03/16/04
Notice of Reopen69 FR 25052 Period                             05/05/04
NODA                                                           11/00/04
Final Action                                                   03/15/05
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


 Businesses


Government Levels Affected:


Federal, Local, State, Tribal


Additional Information:


SAN No. 4571, EDocket No. OAR-2002-0056;


Sectors Affected:


221112 Fossil Fuel Electric Power Generation


URL For More Information:
www.epa.gov/ttn/atw/utility/utiltoxpg.html
Agency Contact:
Robert Wayland
Environmental Protection Agency
Air and Radiation
C439-01
Research Triangle Park, NC 27711
Phone: 919-541-1045
Fax: 919 541-5450
Email: [email protected]

Bill Maxwell
Environmental Protection Agency
Air and Radiation
C439-01
Research Triangle Park, NC 27711
Phone: 919-541-5430
Fax: 919 541-5450
Email: [email protected]
RIN: 2060-AJ65
_______________________________________________________________________



EPA



128. CLEAN AIR OZONE IMPLEMENTATION RULE (PART 1 AND PART 2)
Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


This action may affect the private sector under PL 104-4.


Legal Authority:


42 USC 7408; 42 USC 7410; 42 USC 7501 to 7511f; 42 USC 7601(a)(1)

[[Page 72835]]

CFR Citation:


40 CFR 51; 40 CFR 50; 40 CFR 81


Legal Deadline:


None


Abstract:


This rule would provide specific requirements for State and local air 
pollution control agencies and Tribes to prepare State Implementation 
Plans (SIPs) and Tribal Implementation Plans (TIPs) under the 8-hour 
national ambient air quality standard (NAAQS) for ozone, published by 
EPA on July 18, 1997. The Clean Air Act (CAA) requires EPA to set 
ambient air quality standards and requires States to submit SIPs to 
implement those standards. The 1997 standards were challenged in court, 
but in February 2001, the Supreme Court determined that EPA has 
authority to implement a revised ozone standard, but ruled that EPA 
must reconsider its implementation plan for moving from the 1-hour 
standard to the revised standard. The Supreme Court identified 
conflicts between different parts of the CAA related to implementation 
of a revised NAAQS, provided some direction to EPA for resolving the 
conflicts, and left it to EPA to develop a reasonable approach for 
implementation. Thus, this rulemaking must address the requirements of 
the CAA and the Supreme Court's ruling. This rule would provide 
detailed provisions to address the CAA requirements for SIPs and TIPs 
and would thus affect States and tribes. States with areas that are not 
attaining the 8-hour ozone NAAQS will have to develop--as part of their 
SIPs--emission limits and other requirements to attain the NAAQS within 
the timeframes set forth in the CAA. Tribal lands that are not 
attaining the 8-hour ozone standard may be affected, and could 
voluntarily submit a TIP, but would not be required to submit a TIP. In 
cases where a TIP is not submitted, EPA would have the responsibility 
for planning in those areas.


Statement of Need:


This action is needed in response to the U.S. Supreme Court's ruling in 
February 2001 (Whitman v. American Trucking Assoc., 121 S.Ct.903) that 
stated that EPA has the authority to implement a revised ozone NAAQS 
but that EPA could not ignore the provisions of subpart 2 when 
implementing the 8-hour NAAQS. The Supreme Court identified several 
portions of subpart 2 that are ill-fitted to the revised NAAQS but left 
it to EPA to develop a reasonable implementation approach. 
Consequently, EPA is developing a rule to implement the 8-hour ozone 
NAAQS under the provisions of subpart 2 of the CAA.


Summary of Legal Basis:


Title I of the Clean Air Act


Alternatives:


This entry comprises the action the Agency plans to take to implement 
the 8-hour ozone NAAQS. The major alternatives facing the Agency is 
whether the 8-hour O3 NAAQS should be implemented under the less 
prescriptive part of the Clean Air Act (title I, part D, subpart 1) or 
the more prescriptive part of the Act (subpart 2). Another major set of 
alternatives concern the kind of transition EPA should make from 
implementation of the current 1-hour ozone standard to the new 8-hr 
ozone standard.


Anticipated Cost and Benefits:


EPA prepared a regulatory impact analysis for the final ozone NAAQS, 
and has prepared a cost analysis for the proposed implementation rule. 
The benefits of the rule are those associated with attainment of the 
ozone NAAQS including significant improvements in premature mortality, 
chronic asthma, chronic and acute bronchitis, upper and lower 
respiratory symptoms, work days lost, decreased worker productivity, 
visibility in urban and suburban areas, and increases in yields of 
commercial forests currently exposed to elevated ozone levels.


Risks:


The risks addressed by this action are the likelihood of experiencing 
increased health and environmental effects associated with 
nonattainment of the National Ambient Air Quality Standard for ozone. 
These effects are briefly described above in the ``costs and benefits'' 
section, and they were outlined in detail in the Regulatory Impact 
Analysis for the ozone NAAQS rulemaking. The results are summarized in 
the Federal Register notice for that rulemaking (62 FR 38856, July 18, 
1997).


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            68 FR 32802                                    06/02/03
Final Action (Ph69 FR 23951                                    04/30/04
Final Action (Phase 2)                                         11/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Local, State, Tribal


Additional Information:


SAN No. 4625;


Agency Contact:
John Silvasi
Environmental Protection Agency
Air and Radiation
C539-02
Research Triangle Park, NC 20460
Phone: 919 541-5666
Fax: 919 541-0824
Email: [email protected]

Denise Gerth
Environmental Protection Agency
Air and Radiation
C539-02
Research Triangle Park, NC 20460
Phone: 919 541-5550
Fax: 919 541-0824
Email: [email protected]
RIN: 2060-AJ99
_______________________________________________________________________



EPA



129.  NONATTAINMENT MAJOR NEW SOURCE REVIEW (NSR)
Priority:


Other Significant


Legal Authority:


42 USC 7401 et seq


CFR Citation:


40 CFR 51, app S


Legal Deadline:


None


Abstract:


This final action will promulgate changes to regulations that govern 
NSR permitting of major stationary sources in nonattainment areas where 
there is no approved SIP. Appendix S of 40 CFR part 51 contains the 
permitting program for major stationary sources in nonattainment areas 
in transition periods before approval of a SIP to implement part D of 
title I. This final action will revise appendix S to conform it to the 
changes made to regulations at 40 CFR 51.165 for SIP programs for 
nonattainment major NSR. (67 FR 80816; December 31, 2002)


Statement of Need:


In August 1992, EPA voluntarily initiated a comprehensive effort to 
reform the NSR process. This effort was

[[Page 72836]]

initiated to examine complaints from the regulated community that the 
current regulatory scheme is too complex, needlessly delays projects, 
and unduly restricts source flexibility. Currently there are no 
applicable statutory or judicial deadlines for the NSR reform 
rulemaking effort. The goal of this effort is to address industry's 
concerns without sacrificing the environmental benefits embodied in the 
present approach; that is, protecting and improving local air quality, 
and stimulating pollution prevention and advances in control 
technologies. In July 1993, the NSR Reform Subcommittee of the CAA 
Advisory Committee was formed. The Subcommittee's purpose is to provide 
independent advice and counsel to EPA on policy and technical issues 
associated with reforming the NSR rules. The Subcommittee was composed 
of representatives from industry, State/local air pollution control 
agencies, environmental organizations, EPA headquarters and regions, 
and other Federal agencies (National Park Service and Forest Service, 
Department of Energy, and the Office of Management and Budget).


Summary of Legal Basis:


Clean Air Act sections 165 and 173.


Alternatives:


The Subcommittee discussed numerous options for implementing NSR 
reform. However, EPA's primary focus has been to consider the specific 
recommendations developed by the Subcommittee and, where appropriate, 
use them in this rulemaking effort. In January 1996, EPA, as part of 
another regulatory streamlining measure, merged portions of a separate 
rulemaking to implement the 1990 CAA Amendments with the Reform effort. 
The combined package was proposed in the Federal Register on July 23, 
1996. On July 24, 1998, EPA issued another Federal Register Notice 
seeking comment on two applicability provisions. On February 2-3, 1999, 
EPA convened a public meeting to listen to new stakeholder proposals 
for streamlining NSR applicability and control technology requirements. 
Stakeholder groups submitted written proposals during May and June 
1999.


Anticipated Cost and Benefits:


From a cost perspective, the proposed rulemaking represents a decrease 
in applications and recordkeeping costs to industry of at least $13 
million per year, as compared to the preexisting program, based 
primarily on the fact that fewer sources will need to apply for major 
source permits. In addition, the cost to State and local agencies will 
be reduced by approximately $1.4 million per year. The Federal 
Government should realize a savings of approximately $116,000 per year. 
Additional cost reductions, which are difficult to quantify, will be 
realized due to the streamlining effect of the rulemaking on the 
permitting process, for example, the opportunity costs for shorter time 
periods between permit application and project completion and reduced 
uncertainty in planning for future source growth.


Risks:


This is a procedural rule applicable to a wide variety of source 
categories. Moreover, it applies to criteria pollutants for which NAAQS 
have been established. This action is considered environmentally 
neutral. However, any potential risks are considered in the NAAQS 
rulemaking from a national perspective.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Final Action                                                   11/00/04
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


Federal, Local, State


Additional Information:


SAN No. 3259.2; Split from RIN 2060-AE11. See also SAN 4390


Agency Contact:
Janet McDonald
Environmental Protection Agency
Air and Radiation
C339-03
Washington, DC 20460
Phone: 919-541-1450
Fax: 919 541-5509
Email: [email protected]

Lynn Hutchinson
Environmental Protection Agency
Air and Radiation
C339-03
Research Triangle Park, NC 27711
Phone: 919-541-5795
Fax: 919 541-5509
Email: [email protected]
RIN: 2060-AM59
_______________________________________________________________________



EPA



130. TEST RULE; TESTING OF CERTAIN HIGH PRODUCTION VOLUME (HPV) 
CHEMICALS
Priority:


Other Significant


Legal Authority:


15 USC 2603; 15 USC 2611 to 2612; 15 USC 2625 to 2626


CFR Citation:


40 CFR 790 to 799


Legal Deadline:


None


Abstract:


EPA is proposing test rules under section 4(a) of the Toxic Substances 
Control Act (TSCA) to require testing and recordkeeping requirements 
for certain high production volume (HPV) chemicals (i.e., chemicals 
which are manufactured (including imported) in the aggregate at more 
than 1 million pounds on an annual basis) that have not been sponsored 
under the voluntary HPV Challenge Program. Although varied based on 
specific data needs for the particular chemical, the data generally 
collected under these rules may include: Acute toxicity, repeat dose 
toxicity, developmental and reproductive toxicity, mutagenicity, 
ecotoxicity, and environmental fate. The first rule proposed testing 
for 37 HPV chemicals with substantial worker exposure. The number of 
chemicals included in the first final rule may be reduced based on new 
information on annual production volumes, worker exposure, and 
commitments to the voluntary HPV Challenge Program. Subsequent test 
rules will require similar screening level testing for other 
unsponsored HPV Challenge Program chemicals.


Statement of Need:


EPA has found that, of those non-polymeric organic substances produced 
or imported in amounts equal to or greater than 1 million pounds per 
year based on 1990 reporting for EPA's Inventory Update Rule (IUR), 
only 7 percent have a full set of publicly available internationally 
recognized basic health and environmental fate/effects screening test 
data. Of the over 2,800 HPV chemicals based on 1990 data, 43 percent 
have no publicly available basic hazard data. For the remaining 
chemicals, limited amounts of the data are available. This lack of 
available hazard data compromises EPA's and others' ability to 
determine

[[Page 72837]]

whether these HPV chemicals pose potential risks to human health or the 
environment, as well as the public's right to know about the hazards of 
chemicals that are found in their environment, their homes, their 
workplaces, and the products that they buy. It is EPA's intent to close 
this knowledge gap. EPA believes that for most of the HPV chemicals, 
insufficient data are readily available to reasonably determine or 
predict the effects on health or the environment from the manufacture 
(including importation), distribution in commerce, processing, use, or 
disposal of the chemicals, or any combination of these activities. EPA 
has concluded that a program to collect and, where needed, develop 
basic screening level toxicity data is necessary and appropriate to 
provide information in order to assess the potential hazards/risks that 
may be posed by exposure to HPV chemicals. On April 21, 1998, a 
national initiative, known as the Chemical Right-To-Know Initiative, 
was announced in order to empower citizens with knowledge about the 
most widespread chemicals in commerce--chemicals that people may be 
exposed to in the places where they live, work, study, and play. A 
primary component of EPA's Chemical Right-To-Know (ChemRTK) initiative 
is the voluntary HPV Challenge Program, which was created in 
cooperation with industry, environmental groups, and other interested 
parties, and is designed to assemble basic screening level test data on 
the potential hazards of HPV chemicals while avoiding unnecessary or 
duplicative testing. Data needs which remain unmet in the voluntary HPV 
Challenge Program may be addressed through the international efforts or 
rulemaking.


Summary of Legal Basis:


These test rules will be issued under section 4(a)(1)(B) of TSCA. 
Section 2(b)(1) of TSCA states that it is the policy of the United 
States that ``adequate data should be developed with respect to the 
effect of chemical substances and mixtures on health and the 
environment and that the development of such data should be the 
responsibility of those who manufacture (which is defined by statute to 
include import) and those who process such chemical substances and 
mixtures(.)'' To implement this policy, TSCA section 4(a) mandates that 
EPA require by rule that manufacturers and processors of chemical 
substances and mixtures conduct testing if the Administrator finds 
that: (1)(A)(i) the manufacture, distribution in commerce, processing, 
use, or disposal of a chemical substance or mixture, or that any 
combination of such activities, may present an unreasonable risk of 
injury to health or the environment, (ii) there are insufficient data 
and experience upon which the effects of such manufacture, distribution 
in commerce, processing, use, or disposal of such substance or mixture 
or of any combination of such activities on health or the environment 
can reasonably be determined or predicted, and (iii) testing of such 
substance or mixture with respect to such effects is necessary to 
develop such data; or (B)(i) a chemical substance or mixture is or will 
be produced in substantial quantities, and (I) it enters or may 
reasonably be anticipated to enter the environment in substantial 
quantities or (II) there is or may be significant or substantial human 
exposure to such substance or mixture, (ii) there are insufficient data 
and experience upon which the effects of the manufacture, distribution 
in commerce, processing, use, or disposal of such substance or mixture 
or of any combination of such activities on health or the environment 
can reasonably be determined or predicted, and (iii) testing of such 
substance or mixture with respect to such effects is necesssary to 
develop such data.


Alternatives:


The strategy and overall approach that EPA is using to address data 
collection needs for U.S. HPV chemicals includes a voluntary component 
(the HPV Challenge Program), certain international efforts, and these 
rulemakings under TSCA. The issuance of a rulemaking is often the 
Agency's final mechanism for obtaining this important information.


Anticipated Cost and Benefits:


The potential benefits of these test rules are substantial, as no one--
whether in industry, government, or the public--can make reasoned risk 
management decisions in the absence of reliable health and 
environmental information. The cost of the baseline screening testing 
that would be imposed is estimated to be about $200,000 per chemical 
for a full set of tests. It is unlikely, however, for a chemical to 
need a full set of tests, which would only occur if none of the data in 
question already exists.


Risks:


Data collected and/or developed under these test rules, when combined 
with information about exposure and uses, will allow the Agency and 
others to evaluate and prioritize potential health and environmental 
effects and take appropriate follow up action.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            65 FR 81658                                    12/26/00
Final Action                                                   12/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


Federal


Additional Information:


SAN 3990. See also the Regulatory Plan entry entitled Chemical Right-
to-Know Initiative (RIN 2070-AD25; SAN 4176).


Sectors Affected:


325 Chemical Manufacturing; 32411 Petroleum Refineries


URL For More Information:
www.epa.gov/opptintr/chemtest/sect4rule.htm
Agency Contact:
Catherine Roman
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7405M
Washington, DC 20460
Phone: 202-564-8172
Fax: 202 564-4765
Email: [email protected]

Greg Schweer
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7405M
Washington, DC 20460
Phone: 202-564-8469
Fax: 202 564-4765
Email: [email protected]
RIN: 2070-AD16
_______________________________________________________________________



EPA



131. NESHAPS: STANDARDS FOR HAZARDOUS AIR POLLUTANTS FOR HAZARDOUS 
WASTE COMBUSTORS (PHASE I FINAL REPLACEMENT STANDARDS AND PHASE II)
Priority:


Other Significant

[[Page 72838]]

Legal Authority:


42 USC 6924 RCRA 3004; 42 USC 6925 RCRA 3005; 42 USC 7412 CAA 112; 42 
USC 7414 CAA 114


CFR Citation:


40 CFR 63; 40 CFR 264; 40 CFR 265; 40 CFR 266; 40 CFR 270


Legal Deadline:


NPRM, Judicial, March 31, 2004, Consent decree for Phase 2 portion of 
rule.


Final, Judicial, June 14, 2005, Consent decree.


Abstract:


On September 30, 1999, EPA promulgated standards to control emissions 
of hazardous air pollutants from incinerators, cement kilns, and 
lightweight aggregate kilns that burn hazardous waste (referred to as 
the Phase I Rule). A number of parties, representing interests of both 
industry and the environmental community, sought judicial review of the 
rule. The Court ruled against EPA and vacated the Phase I rule. On 
October 19, 2001, EPA, together with all petitioners, filed a joint 
motion asking the Court to stay the issuance of its mandate to allow 
them time to develop interim standards. These stop-gap interim 
standards were promulgated on February 13 and 14, 2002. They replace 
the vacated standards temporarily, until revised replacement standards 
are promulgated by June 14, 2005. EPA will ultimately finalize the 
Phase I replacement standards. Also, EPA is developing emission 
standards for hazardous waste burning industrial, institutional, 
commercial boilers, process heaters, and hydrochloric acid production 
furnaces. These sources are referred to as Phase II Sources because the 
standards were originally scheduled to be promulgated after Phase I 
source standards were finalized; however, a separate consent decree now 
requires us to finish developing emission standards for the Phase II 
sources by the same date as those for Phase I (June 14, 2005). EPA has 
developed options for calculating the emission standards that are 
considered to be consistent with both the statutory requirements and 
the opinion of the Court. EPA has proposed emission standards and 
compliance provisions for both the Phase I and Phase II sources.


Statement of Need:


Section 112 of the Clean Air Act requires that the EPA promulgate 
regulations requiring the control of hazardous air pollutants from 
major and certain area sources. The control of hazardous air pollutants 
is achieved through promulgation of emission standards under sections 
112(d) and (f) and, in appropriate circumstances, work practice 
standards under section 112(h).


On September 30, 1999 EPA promulgated standards to control emissions of 
hazardous air pollutants from incinerators, cement kilns, and 
lightweight aggregate kilns that burn hazardous waste (referred to as 
the Phase I Rule). A number of parties, representing interests of both 
industry and the environmental community, sought judicial review of the 
rule. The Court ruled against EPA and vacated the Phase I rule.


Summary of Legal Basis:


On October 19, 2001, EPA, together with all petitioners, filed a joint 
motion asking the Court to stay the issuance of its mandate to allow 
time to develop interim standards. These stop-gap interim standards 
were promulgated on February 13 and 14, 2002. They replace the vacated 
standards temporarily, until revised replacement standards are 
promulgated by June 14, 2005. EPA is working towards promulgation by 
this date. EPA is also developing emission standards for hazardous 
waste burning industrial, institutional, commercial boilers, process 
heaters, and hydrochloric acid production furnaces. These sources are 
referred to as Phase II Sources because the standards were originally 
scheduled to be promulgated after Phase I source standards were 
finalized; however, a separate consent decree now requires us to finish 
developing emission standards for the Phase II sources by the same date 
as those for Phase I (June 14, 2005).


Alternatives:


EPA has developed several options for calculating the emission 
standards and has included these options in the April 20, 2004 
proposal.


Anticipated Cost and Benefits:


Estimated costs and benefits for the proposed standards are summarized 
in the April 20, 2004 proposal.


Risks:


For the 1999 rule, we estimated the avoided incidence of mortality and 
morbidity associated with reductions in particulate matter (PM) 
emissions. Estimates of cases of mortality and morbidity avoided were 
made for children and the elderly, as well as the general population, 
using concentration-response functions derived from human 
epidemiological studies. Morbidity effects included respiratory and 
cardiovascular illnesses requiring hospitalization, as well as other 
illnesses not requiring hospitalization, such as acute and chronic 
bronchitis and acute upper and lower respiratory symptoms. For this 
rule, we are comparing characteristics of the sources covered by the 
1999 rule to the sources covered by the replacement rule that are 
related to risk. These characteristics include emissions, stack 
characteristics, meteorology, and population. Based on the results of 
the statistical comparisons, we will infer whether the risks will be 
about the same, less than, or greater than the 1999 rule. Risk 
inferences for boilers and HCl production furnaces will be based on 
comparisons with incinerators for the 1999 rule. The risk estimates for 
the proposed standards are summarized in the April 20, 2004 proposal.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM-CK         61 FR 17358                                    04/19/96
Final-Fasttrack 63 FR 33782                                    06/19/98
Final-CK        64 FR 52828                                    09/30/99
NODA            65 FR 39581                                    07/27/00
DF 1            66 FR 35087                                    07/03/01
NPRM-Phase1     66 FR 35126                                    07/03/01
Parallel Proposa66 FR 35124                                    07/03/01
Direct Final Act66 FR 52361                                    10/15/01
Final Compliance66 FR 63313                                    12/06/01
Interim Final Ac67 FR 6792                                     02/13/02
Final HAP       67 FR 6968                                     02/14/02
NPRM-Phases 1&2 69 FR 21197                                    04/20/04
Final Action                                                   06/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


Federal, State, Tribal


Additional Information:


SAN No. 3333, EDocket No. OAR-2004-0022; For information on the Phase I 
portion of this effort, see SAN 4418, RIN 2050-AE79.


Sectors Affected:


3335 -; 3343 Audio and Video Equipment Manufacturing; 3251 Basic 
Chemical Manufacturing; 3273 Cement and Concrete Product Manufacturing; 
3271 Clay Product and Refractory Manufacturing; 3328 Coating, 
Engraving, Heat Treating and Allied

[[Page 72839]]

Activities; 3342 Communications Equipment Manufacturing; 3341 Computer 
and Peripheral Equipment Manufacturing; 2211 Electric Power Generation, 
Transmission and Distribution; 45431 Fuel Dealers; 3332 Industrial 
Machinery Manufacturing; 3274 Lime, Gypsum and Gypsum Product 
Manufacturing; 3327 Machine Shops, Turned Product, and Screw, Nut and 
Bolt Manufacturing; 3362 Motor Vehicle Body and Trailer Manufacturing; 
3361 Motor Vehicle Manufacturing; 3363 Motor Vehicle Parts 
Manufacturing; 2123 Non-Metallic Mineral Mining and Quarrying; 3259 
Other Chemical Product Manufacturing; 3329 Other Fabricated Metal 
Product Manufacturing; 3339 Other General Purpose Machinery 
Manufacturing; 3279 Other Nonmetallic Mineral Product Manufacturing; 
3255 Paint, Coating, Adhesive, and Sealant Manufacturing; 3253 
Pesticide, Fertilizer and Other Agricultural Chemical Manufacturing; 
3241 Petroleum and Coal Products Manufacturing; 4227 Petroleum and 
Petroleum Products Wholesalers; 3254 Pharmaceutical and Medicine 
Manufacturing; 3231 Printing and Related Support Activities; 5629 
Remediation and Other Waste Management Services; 3252 Resin, Synthetic 
Rubber, and Artificial and Synthetic Fibers and Filaments 
Manufacturing; 3344 Semiconductor and Other Electronic Component 
Manufacturing; 22132 Sewage Treatment Facilities; 5622 Waste Treatment 
and Disposal


URL For More Information:
www.epa.gov/hwcmact/
Agency Contact:
Michael Galbraith
Environmental Protection Agency
Solid Waste and Emergency Response
5302W
Washington, DC 20460
Phone: 703-605-0567
Fax: 703 308-8433
Email: [email protected]

Frank Behan
Environmental Protection Agency
Solid Waste and Emergency Response
5302W
Washington, DC 20460
Phone: 703-308-8476
Fax: 703 308-8433
Email: [email protected]
RIN: 2050-AE01
_______________________________________________________________________



EPA



132. HAZARDOUS WASTE MANIFEST REGULATION
Priority:


Other Significant


Legal Authority:


42 USC 6922 RCRA 3002; 42 USC 6923 RCRA 3003; 42 USC 6924 RCRA 3004; 42 
USC 6926 RCRA 3006; PL 105-277; Government Paperwork Elimination Act 17


CFR Citation:


40 CFR 260; 40 CFR 262; 40 CFR 263; 40 CFR 264; 40 CFR 265; 40 CFR 271


Legal Deadline:


None


Abstract:


The Uniform Hazardous Waste Manifest (Form 8700-22) is a multi-copy 
form used to identify the quantity, composition, origin, routing, and 
destination of hazardous waste during its transportation. Waste 
handlers (e.g., generators and transporters) are required to use the 
manifest, and States may not require a different manifest in its place. 
However, the manifest has State blocks which allow States, at their 
option, to require the entry of additional specific information to 
serve their State's regulatory needs. Under the current regulations 
more than 20 states print the manifest form in accordance with the 
format specified in Federal regulations. However, the variability among 
State manifest programs associated with State optional blocks, 
different copy distribution schemes, and the manifest hierarchical 
acquisition scheme has drawn complaints from the regulated community. 
Variability among States' manifest programs and the manifest system's 
current reliance on paper result in significant paperwork and cost 
burden to waste handlers and States who choose to collect manifest 
information. The Agency intends to standardize further the manifest 
form elements, and to specify one format for the manifests that may be 
used in all States. In addition, the Agency intends to announce 
standard requirements for tracking rejected wastes, container residues, 
and international shipments of hazardous wastes. Finally, the Agency 
intends to pursue an optional approach that would use information 
technologies to conduct the manifest process electronically, thereby 
reducing paperwork burden, and improving the speed and accuracy of 
preparing, transmitting, and recordkeeping the manifest form. However, 
the Agency will bifurcate the manifest rule so that the form revisions 
may be expedited, while additional analysis on the e-manifest 
continues.


Statement of Need:


Since the adoption of the Uniform Manifest by EPA and the Department of 
Transportation (DOT) in 1984, the regulated community and authorized 
States have pressed EPA to adopt changes that would simplify and 
further reduce the variability among the hazardous waste manifest forms 
required and distributed by the States. In addition, the recent focus 
on electronic government has highlighted the potential advantages of an 
electronic manifest system in terms of reduced paperwork burdens and 
more timely waste tracking. This action responds to these needs with a 
truly universal set of manifest data elements and a manifest format 
that will be identical in all States, as well as standards that will 
allow the manifest data to be completed, signed, transmitted, and 
recorded electronically.


Summary of Legal Basis:


EPA's regulations implementing the manifest are based on section 
3002(a)(5) of the RCRA statute, which requires that EPA include in its 
hazardous waste generator regulations requirements addressing the ``use 
of a manifest system and ony other reasonable means necessary'' to 
assure that all such hazardous waste is designated for and arrives at 
treatment, storage, or disposal facilities that have been permitted 
under RCRA subtitle C requirements. Secion 3003(a)(3) of the Act 
requires transporters of hazardous waste to comply with the manifest 
system, while section 3004(a)(2) requires compliance with the manifest 
system by treatment, storage, and disposal facilities. Moreover, 
according to section 1004(12) of the Act, the manifest is defined as 
the ``form used for identifying the quantity, composition, and the 
origin, routing, and destination of hazardous waste during its 
transportation from the point of generation to the point of disposal, 
treatment, or storage.'' The manifest also serves as the ``shipping 
paper'' meeting DOT requirements for the transportation of hazardous 
materials under the Federal Hazardous Materials laws and regulations.


EPA's current manifest regulations require generators to obtain 
manifest forms from the authorized States. The generator must complete 
the paper form by identifying the type and quantity of

[[Page 72840]]

hazardous waste in off-site shipments, as well as the identities of the 
transporters and waste receiving facilities that will manage the waste. 
The regulations require waste handlers to sign the manifest form by 
hand when they receive a waste shipment, and to retain copies of the 
signed manifests that document the chain of custody of a shipment, and 
any discrepancies.


EPA and DOT have authority to eliminate variability among State 
manifests, since DOT's hazardous materials laws generally call for 
uniformity in the use of hazardous materials shipping papers such as 
the manifest, and EPA must regulate transportation consistently with 
DOT. EPA and DOT consented in 1984 to the inclusion of several 
``optional'' data fields, but our experience with the manifest system 
has demonstrated that the inclusion of optional fields introduces 
excessive variability and burden for waste handlers. EPA also has 
authority to automate the waste tracking functions of the manifest, 
since the Act states that EPA can employ any reasonable means necessary 
to track waste shipments under a manifest system. There is nothing in 
the statute that precludes EPA from establishing standards allowing 
electronic manifesting of shipments, as well as use of the traditional 
paper forms.


Alternatives:


The form revisions part of the rulemaking examines alternatives to the 
current system that allows authorized States to print and distribute 
slightly varying manifest forms (typically for a fee) to waste handlers 
generating or shipping waste in a particular State. This rule would 
establish a precise Federal specification for the manifest that would 
preclude variability in manifest forms, wherever they are used. This 
option was proposed in May 2001, and was supported by the great 
preponderance of commenters who submitted written comments to the 
docket.


The rule also examines alternative electronic formats for completing 
electronic manifests, and alternative methods for signing manifests 
electronically. Moreover, EPA has been examining in response to 
comments whether electronic manifest systems should be developed in a 
decentralized fashion by private companies in adherence with standards 
announced by EPA (the proposed approach), or developed and hosted 
centrally in a national system. We expect that additional stakeholder 
outreach will be necessary to determine the appropriate design and 
functionality of the e-manifest approach for the final rule. Therefore, 
the e-manifest part of the rulemaking has been separated from the form 
revisions part of the rule, so that final action on the form revisions 
will not be delayed by future outreach and analysis conducted in 
connection with the e-manifest.


Anticipated Cost and Benefits:


The baseline manifest system results in annual paperwork burdens of 4.6 
million hours and annual costs of about $193 million. In developing the 
May 2001, proposed rule, EPA estimated that the proposed revisions to 
the hazardous waste manifest system (form changes and electronic 
manifest) would reduce the paperwork burdens imposed by the manifest by 
765,000 to 1.24 million hours annually, and would reduce annual costs 
by $24 to $37 million. The rule should also eliminate much of the 
complexity that arises from having to obtain and comply with States' 
slightly varying manifest forms, and the burden and complexity of 
having to supply information to satisfy the current so-called 
``optional'' State fields. The ability to complete and transmit 
manifest data electronically should improve the accuracy of manifest 
data, and the timeliness and effectiveness of waste shipment tracking.


Risks:


This rule addresses only administrative requirements for tracking waste 
shipments. The rule does not address risks posed by particular 
substances or waste management activities, and no risk assessments have 
been prepared to support this action.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            66 FR 28240                                    05/22/01
Final Action                                                   01/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, State


Additional Information:


SAN No. 3147, EDocket No. RCRA-2001-0032; Because of significant issues 
identified during the public comment period on the electronic manifest 
part of the rule, this part of the rule has been separated from the 
form revisions part of the rule for purposes of publishing a final 
action. The form revisions part of the rule will be finalized first.


Sectors Affected:


325 Chemical Manufacturing; 2211 Electric Power Generation, 
Transmission and Distribution; 332 Fabricated Metal Product 
Manufacturing; 2122 Metal Ore Mining; 2111 Oil and Gas Extraction; 326 
Plastics and Rubber Products Manufacturing; 331 Primary Metal 
Manufacturing; 323 Printing and Related Support Activities; 3221 Pulp, 
Paper, and Paperboard Mills; 482 Rail Transportation; 484 Truck 
Transportation; 5621 Waste Collection; 5622 Waste Treatment and 
Disposal; 483 Water Transportation


URL For More Information:
http://www.epa.gov/epaoswer/hazwaste/gener/manifest/index.htm
Agency Contact:
Rich Lashier
Environmental Protection Agency
Solid Waste and Emergency Response
5304W
Washington, DC 20460
Phone: 703-308-8796
Fax: 703 308-0522
Email: [email protected]

Bryan Groce
Environmental Protection Agency
Solid Waste and Emergency Response
5304W
Washington, DC 20460
Phone: 703-308-8750
Fax: 703 308-0522
Email: [email protected]
RIN: 2050-AE21
_______________________________________________________________________



EPA



133. STANDARDIZED PERMIT FOR RCRA HAZARDOUS WASTE MANAGEMENT FACILITIES
Priority:


Other Significant


Legal Authority:


42 USC 6905; 42 USC 6912; 42 USC 6924; 42 USC 6925; 42 USC 6927; 42 USC 
6974


CFR Citation:


40 CFR 124; 40 CFR 267; 40 CFR 270


Legal Deadline:


None

[[Page 72841]]

Abstract:


EPA has proposed creating a new type of general permit, called a 
standardized permit, for facilities that generate waste and routinely 
manage the waste on-site in tanks, containers, and containment 
buildings. Under the standardized permit, facility owners and operators 
would certify compliance with generic design and operating conditions 
set on a national basis. The permitting agency would review the 
certifications submitted by the facility owners and operators. The 
permitting agency would also be able to impose additional site-specific 
terms and conditions for corrective action or other purposes, as called 
for by RCRA. Ensuring compliance with the standardized permit's terms 
and conditions would occur during inspection of the facility after the 
permit has been issued. The standardized permit should streamline the 
permit process by allowing facilities to obtain and modify permits more 
easily while maintaining the protectiveness currently existing in the 
individual RCRA permit process. EPA estimates that the potential 
average annual cost savings to eligible facilities from implementation 
of this rule will range from approximately $100 to $5,800 (i.e., 2 to 
140 burden hours) per permit action, depending on such things as the 
type of permit and the type of storage equipment. The proposal raised 
issues for public comment on how all facilities receiving RCRA permits 
can satisfy RCRA corrective action requirements under appropriate 
alternative State cleanup programs and on financial assurance issues. 
The Agency is developing a final rule addressing this topic.


Statement of Need:


The Agency convened a special task force in 1994 to look at permitting 
activities throughout its different programs and to make specific 
recommendations to improve these permitting programs. This task force, 
known as the Permits Improvement Team (PIT), spent two years working 
with stakeholders from the Agency, State permitting agencies, industry, 
and the environmental community. The PIT stakeholders mentioned, among 
other things, that permitting activities should be commensurate with 
the complexity of the activity. The stakeholders felt that current 
Agency permitting programs were not flexible enough to allow 
streamlined procedures for routine permitting activities. Currently, 
facilities that store, treat, or dispose of hazardous waste must obtain 
site-specific ``individual'' permits prescribing conditions for each 
``unit'' (e.g., tank, container area, etc.) in which hazardous waste is 
managed. Experience gained by the Agency and States over the past 15 
years has shown that not all the waste management activities are at the 
same level of complexity. Some activities, such as thermal treatment or 
land disposal of hazardous wastes, are more complex than storage of 
hazardous waste. The Agency believes that thermal treatment and land 
disposal activities continue to warrant ``individual'' permits, 
prescribing unit-specific conditions. However, the Agency believes that 
some accommodation can be made for hazardous waste management practices 
in standardized units such as tanks, container storage areas, and 
containment buildings. In April 1996, the PIT tentatively recommended, 
among other things, that regulations be developed to allow 
``standardized permits'' for on-site storage and non-thermal treatment 
of hazardous waste in tanks, containers, and containment buildings. On 
October 12, 2001, the Agency proposed revising the RCRA regulations to 
allow for this type of permit, and is preparing to finalize the rule.


Summary of Legal Basis:


Facilities that manage hazardous waste are required under RCRA to 
obtain a permit and carry out corrective action as necessary (see: RCRA 
sections 3004, 3005, 3008, and 3010). EPA has discretion under these 
statutory provisions to apply different permitting procedures to 
different types of facilities. No aspect of this streamlining action is 
required by court order.


Alternatives:


EPA considered several options regarding RCRA permits and corrective 
action alternatives. The Agency proposed to limit the scope of the rule 
to facilities that generate waste and manage it on-site, but asked for 
comment on whether to expand that scope to facilities that manage 
wastes generated off-site. The Agency also asked for comment on the 
option of allowing a facility's RCRA corrective action activities to be 
postponed if corrective action is being carried out under an approved 
State remedial program.


Anticipated Cost and Benefits:


The RCRA standardized permit is an optional rule designed to streamline 
the regulatory burden to EPA/States, as well as to private sector 
facilities covered by the rule, by reducing the amount of information 
collected, submitted, and reviewed for RCRA hazardous waste permit 
actions (i.e., new permit applications, permit modifications, and 
permit renewals). Because the rule proposed to streamline existing RCRA 
regulation, rather than add new RCRA regulation, implementation of the 
rule by the EPA and by States with EPA-authorized permitting programs 
is expected to result in economic benefits in the form of national cost 
savings from reducing both government and private sector resources 
required for the RCRA permit process. The national workload level of 
RCRA permit actions involving on-site hazardous waste storage and non-
thermal treatment units has averaged 92 permit determinations per year 
over the 10-year period 1990-1999. Relative to this average annual 
workload, EPA estimates that the potential average annual cost savings 
to eligible facilities from implementation of this rule will range from 
approximately $100 to $5,800 (i.e., 2 to 140 burden hours) per permit 
action, depending on such things as the type of permit and the type of 
storage equipment. On a national basis, the rule is expected to 
generate a minimum of $0.36 to $0.53 million in average annual 
paperwork cost savings, based on the scope of the proposed rule, which 
was limited to on-site waste management facilities. However, the final 
rule may expand the initial scope of eligible facilities, which could 
easily double or triple the national cost savings benefits (i.e., $1.1 
to $1.6 million per year in cost savings).


Risks:


The purpose of this rule is to streamline existing RCRA permit 
application and issuance procedures to achieve national paperwork 
burden reduction. Because of the facts that facilities covered by this 
rule: (a) Are currently already required to obtain RCRA permits, and 
(b) are relatively simple to design, install/construct, operate, and 
clean-close, this rule is expected to have minimal incremental effects 
on existing levels of human health and environmental risk for these 
types of hazardous waste management facilities.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            66 FR 52192                                    10/12/01
Final Action                                                   04/00/05
Regulatory Flexibility Analysis Required:


No

[[Page 72842]]

Small Entities Affected:


No


Government Levels Affected:


Federal, State


Additional Information:


SAN No. 4028;


Sectors Affected:


3251 Basic Chemical Manufacturing; 332813 Electroplating, Plating, 
Polishing, Anodizing and Coloring; 32551 Paint and Coating 
Manufacturing; 32532 Pesticide and Other Agricultural Chemical 
Manufacturing; 32411 Petroleum Refineries; 325211 Plastics Material and 
Resin Manufacturing; 3252 Resin, Synthetic Rubber, and Artificial and 
Synthetic Fibers and Filaments Manufacturing


Agency Contact:
Jeff Gaines
Environmental Protection Agency
Solid Waste and Emergency Response
5303W
Washington, DC 20460
Phone: 703-308-8655
Fax: 703-308-8609
Email: [email protected]
RIN: 2050-AE44
_______________________________________________________________________



EPA



134. RCRA BURDEN REDUCTION INITIATIVE
Priority:


Other Significant


Legal Authority:


42 USC 6907; 42 USC 6912(a); 42 USC 6921; 42 USC 6922; 42 USC 6923; 42 
USC 6924; 42 USC 6925; 42 USC 6926; 42 USC 6927; 42 USC 6930; 42 USC 
6934; 42 USC 6935; 42 USC 6937; 42 USC 6938; 42 USC 6939; 42 USC 6944; 
42 USC 6949(a); 42 USC 6974; PL 104-13


CFR Citation:


40 CFR 261.38; 40 CFR 264.16; 40 CFR 264.52; 40 CFR 264.56; 40 CFR 
264.73; 40 CFR 264.98 et seq; 40 CFR 265.16; 40 CFR 265.52; 40 CFR 
265.56; 40 CFR 265.73; 40 CFR 265.98 et seq; 40 CFR 266.103; 40 CFR 
261.4; 40 CFR 268.7; 40 CFR 268.9


Legal Deadline:


None


Abstract:


EPA plans to reduce the burden imposed by the RCRA reporting and 
recordkeeping requirements to help meet the Federal Governmentwide goal 
established by the Paperwork Reduction Act (PRA).


In June 1999, EPA published a Notice of Data Availability (NODA) in the 
Federal Register (64 FR 32859) to seek comment on a number of burden 
reduction ideas to eliminate duplicative and nonessential paperwork. 
After reviewing the comments received on the NODA, EPA proposed (67 FR 
2518, 1/17/02) to implement many of these ideas. EPA issued a notice 
(68 FR 61662; 10/29/03) seeking further input on a number of changes we 
proposed. EPA plans to finalize this burden reduction effort.


Statement of Need:


The Paperwork Reduction Act of 1995 establishes a Federal 
Governmentwide goal to reduce the paperwork and reporting burden it 
imposes. The RCRA Burden Reduction Initiative Proposed Rulemaking makes 
the regulatory changes necessary to meet this goal.


Summary of Legal Basis:


This action is not required by statute or court order.


Alternatives:


Reducing recordkeeping and reporting will require changes in our 
regulations. There was no alternative to doing a rulemaking. The Agency 
sought opinions from the regulated community on various burden 
reduction possibilities.


Anticipated Cost and Benefits:


Our cost-benefit analysis showed a savings of $120 million and 929,000 
hours for the final rule. The rule will have minimal impact on the 
protectiveness of the RCRA regulations. It will eliminate or streamline 
paperwork requirements that are unnecessary because they add little to 
the protectiveness of the RCRA regulations.


Risks:


The rule will have no risk impacts.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NODA 1          64 FR 32859                                    06/18/99
NPRM            67 FR 2518                                     01/17/02
NODA 2          68 FR 61662                                    10/29/03
Final Action                                                   08/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, Local, State, Tribal


Additional Information:


SAN No. 4084; Applicable SIC codes: Chemicals and Allied Products (28), 
Primary Metal Industries (33), Fabricated Metals (34), Industrial 
Machinery and Equipment (35), Electrical Equipment (36), Transportation 
Equipment (37), Other Manufacturing, Transportation and Utilities (40-
49), Wholesale Trade (50-51), Services (70-89) and Other SIC Groups


Sectors Affected:


325 Chemical Manufacturing; 334 Computer and Electronic Product 
Manufacturing; 332 Fabricated Metal Product Manufacturing; 324 
Petroleum and Coal Products Manufacturing; 326 Plastics and Rubber 
Products Manufacturing; 331 Primary Metal Manufacturing; 323 Printing 
and Related Support Activities; 562 Waste Management and Remediation 
Services


Agency Contact:
Elaine Eby
Environmental Protection Agency
Solid Waste and Emergency Response
5302W
Washington, DC 20460
Phone: 703-308-8449
Fax: 703 308-8433
Email: [email protected]
RIN: 2050-AE50
_______________________________________________________________________



EPA



135. RECYCLING OF CATHODE RAY TUBES (CRTS): CHANGES TO HAZARDOUS WASTE 
REGULATIONS
Priority:


Other Significant


Legal Authority:


42 USC 6912(a); 42 USC 6921; 42 USC 6922; 42 USC 6923; 42 USC 6924; 42 
USC 6925


CFR Citation:


40 CFR 261; 40 CFR 273


Legal Deadline:


None


Abstract:


This action will ultimately revise the existing Federal hazardous waste 
regulations to encourage recycling and better management of Cathode Ray

[[Page 72843]]

Tubes (CRTs) by providing a conditional exclusion from the definition 
of solid waste for CRTs being recycled. A CRT is the display component 
of a television or computer monitor. A CRT is made largely of 
specialized glasses, some of which contain lead to protect the user 
from X-rays inside the CRT. Due to the lead, when they are disposed of 
or reclaimed, some CRTs are hazardous wastes under the Federal Resource 
Conservation and Recovery Act (RCRA) regulations.


Statement of Need:


This rule is needed to respond to recommendations of the Electronics 
Subcommittee of the CSI Council regarding CRT recycling. It is also 
needed to streamline RCRA requirements for these materials to encourage 
better management and recycling.


Summary of Legal Basis:


This action is not required by statute or court order.


Alternatives:


EPA solicited comments on alternative management requirements, 
including notification and tracking, accumulation requirements, 
requirements for CRT glass processors, export requirements, and 
disposal requirements.


Anticipated Cost and Benefits:


EPA estimates that, if finalized, this action would result in annual 
savings of up to 3 million dollars to reduce administrative, 
transportation, and management costs compared to current regulations.


Risks:


The risks are undetermined.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            67 FR 40507                                    06/12/02
Final Action                                                   08/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, Local, State, Tribal


Additional Information:


SAN No. 4092, EDocket No. RCRA-2004-0010 (CRTs) RCRA-2004-0012 (Mercury 
devices);


Sectors Affected:


334411 Electron Tube Manufacturing


Agency Contact:
Marilyn Goode
Environmental Protection Agency
Solid Waste and Emergency Response
5304W
Washington, DC 20460
Phone: 703-308-8800
Fax: 703 308-0514
Email: [email protected]
RIN: 2050-AE52
_______________________________________________________________________



EPA



136.  HAZARDOUS WASTE MANAGEMENT SYSTEM; MODIFICATION OF THE 
HAZARDOUS WASTE PROGRAM: MERCURY-CONTAINING EQUIPMENT
Priority:


Other Significant


Legal Authority:


42 USC 6912(a); 42 USC 6921; 42 USC 6922; 42 USC 6923; 42 USC 6924; 42 
USC 6925


CFR Citation:


40 CFR 261; 40 CFR 273


Legal Deadline:


None


Abstract:


Mercury-containing equipment (MCE) consists of devices, items, or 
articles that contain varying amounts of elemental mercury that is 
integral to their functions, including several types of instruments 
that are used throughout the electric utility industry and other 
industries, municipalities, and households. Some commonly recognized 
devises are thermostats, barometers, manometers, and mercury switches, 
such as light switches in automobiles. This definition does not include 
mercury waste that is generated as a byproduct through the process of 
manufacturing or treatment. This action will add mercury-containing 
equipment to the federal list of universal wastes regulated under the 
Resource Conservation and Recovery Act (RCRA) hazardous waste 
regulations. Handlers of universal wastes are subject to less stringent 
standards for storing, transporting, and collecting these wastes. EPA 
believes that regulating spent mercury-containing equipment as a 
universal waste will lead to better management of this equipment and 
will facilitate compliance with hazardous waste requirements.


Statement of Need:


This rule is needed to respond to a petition from the Utilities Solid 
Waste Activities Group regarding management of mercury-containing 
equipment. It is also needed to streamline RCRA requirements for these 
materials to encourage better management and recycling and to reduce 
management of mercury in the municipal waste system.


Summary of Legal Basis:


This action is not required by statute or court order.


Alternatives:


EPA solicited comments on alternative management requirements and 
alternative approaches for meeting its goals with respect to mercury 
equipment management.


Anticipated Cost and Benefits:


EPA estimates that, if finalized, this action would result in annual 
savings of up to $270,000 to reduce administrative, transportation, and 
management costs compared to current regulations. In addition, this 
action would improve management of mercury wastes from small and large 
generators and increase collection of these materials for proper 
management.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Final Action                                                   06/00/05
Regulatory Flexibility Analysis Required:


DATA MISSING


Government Levels Affected:


Federal, Local, State, Tribal


Additional Information:


SAN No. 4092.1, EDocket No. RCRA-2004-0010 (CRTs) RCRA-2004-0012 
(Mercury devices); Split from RIN 2050-AE52.


Agency Contact:
Katherine Blanton
Environmental Protection Agency
Solid Waste and Emergency Response
5304W
Washington, DC 20460
Phone: 703-605-0761
Fax: 703 308-0514
Email: [email protected]
RIN: 2050-AG21

[[Page 72844]]

_______________________________________________________________________



EPA



137. NATIONAL PRIMARY DRINKING WATER REGULATIONS: GROUNDWATER RULE
Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


This action may affect the private sector under PL 104-4.


Legal Authority:


42 USC 300 g-1 SDWA 1412 (b)(8); 42 USC 300j-4 SDWA 1445


CFR Citation:


40 CFR 141; 40 CFR 142


Legal Deadline:


Other, Statutory, Not later than promulgation of the Stage 2 
Disinfection Byproducts Rule (currently scheduled for July 2005).


Abstract:


EPA has proposed a targeted risk-based regulatory strategy for all 
public water systems served by groundwater. The proposed requirements 
provide a meaningful opportunity to reduce public health risk for a 
significant number of people served by groundwater sources from the 
exposure to waterborne pathogens from fecal contamination. The proposed 
strategy addresses risks through a multiple-barrier approach that 
relies on five major components: periodic sanitary surveys of 
groundwater systems requiring the evaluation of eight elements and the 
identification of significant deficiencies; hydrogeologic assessments 
to identify wells sensitive to fecal contamination; source water 
monitoring for systems drawing from sensitive wells without treatment 
or with other indications of risk; a requirement for correction of 
significant deficiencies and fecal contamination through the following 
actions: eliminate the source of contamination, correct the significant 
deficiency, provide an alternative source water, or provide a treatment 
which achieves at least 99.99 percent (4-log) inactivation or removal 
of viruses; and compliance monitoring to insure disinfection treatment 
is reliably operated where it is used.


Statement of Need:


Public water systems (PWSs) that use groundwater as their sole source 
of water, as opposed to surface water PWSs, are not federally regulated 
as to treatment for microorganisms. There is data that indicates that a 
number of groundwater PWSs are contaminated with microorganisms of 
fecal origin that can and have caused illness.


Summary of Legal Basis:


Section 1412(b)(8) of the Safe Drinking Water Act requires that EPA 
develop regulations specifying the use of disinfectants for ground 
water systems as necessary and ``. . .(as part of the regulations) 
promulgate criteria. . .to determine whether disinfection shall be 
required as a treatment technique for any public water system served by 
ground water.''


Alternatives:


EPA considered four regulatory alternatives in the development of the 
GWR proposal; the proposed regulatory alternative (multi-barrier 
option), the sanitary survey option, the sanitary survey and triggered 
monitoring option, and the across-the-board disinfection option. All 
options include the sanitary survey provision. The sanitary survey 
option would require the primacy agency to perform surveys every three 
to five years, depending on the type of system. If any significant 
deficiency is identified, a system is required to correct it. The 
sanitary survey and triggered monitoring option adds a source water 
fecal indicator monitoring requirement triggered by a total coliform 
positive sample in the distribution system. The multi-barrier option, 
which was proposed by EPA, adds a hydrogeologic sensitivity assessment 
to these elements which, if a system is found to be sensitive, results 
in a routine source water fecal indicator monitoring requirement. The 
multi-barrier option and the sanitary survey and triggered monitoring 
options are targeted regulatory approaches designed to identify wells 
that are fecally contaminated or are at a high risk for contamination. 
The across-the-board disinfection option would require all systems to 
install treatment instead of trying to identify only the high risk 
systems; therefore, it has no requirement for sensitivity assessment or 
microbial monitoring.


Anticipated Cost and Benefits:


EPA estimates the cost of the proposed GWR will be $183 million dollars 
per year (using a 3 percent discount rate). More than half of the 
estimated costs are for corrective actions which systems will be 
required to take to fix or prevent fecal contamination. The remainder 
of the costs are due to increased scope and frequency of sanitary 
surveys, hydrogeologic sensitivity assessments and source water 
monitoring. System costs are expected to be $162 million per year for 
implementation of the GWR. States are expected to incur costs of $21 
million per year. Cost estimates do not include land acquisition, 
public notification or the potential cost of illness due to exposure to 
disinfection by-products. The total estimated value of these benefits 
is $205 million per year, $139 million from avoided illness and $66 
million from avoided deaths. These benefits are monetized based on a 
cost of illness and a value of statistical life. These estimates do not 
include pain and suffering associated with viral and bacterial illness 
avoided outbreak response costs (such as the costs of providing public 
health warnings and boiling drinking water), and possibly the avoided 
costs of averting behavior and reduced uncertainty about drinking water 
quality.


Risks:


EPA estimates that currently over 200,000 illnesses and 18 deaths occur 
each year due to viral and bacterial contamination of public 
groundwater systems. Children, the elderly and the immunocompromised 
are particularly sensitive to the waterborne pathogens and account for 
between 20 and 30 percent of the illnesses and deaths. As proposed, the 
GWR is expected to reduce the total number of illnesses by 115,000 and 
the total number of deaths by 11 each year. The GWR in conjunction with 
the Surface Water Treatment Rule (SWTR), Total Coliform Rule (TCR) the 
Interim Enhanced Surface Water Treatment Rule (IESWTR), the Filter 
Backwash Rule (FBR) and the Long Term Enhanced Surface Water Treatment 
Rules (LT1ESWTR and LT2ESWTR) will provide protections to the consumers 
of public water supply systems from waterborne pathogens.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            65 FR 30194                                    05/10/00
Final Action                                                   05/00/05
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Federal, Local, State, Tribal

[[Page 72845]]

Additional Information:


SAN No. 2340; Statutory deadline for final rule: After August 6, 1999, 
but not later than the Administrator promulgates a Stage II rulemaking 
for disinfection byproducts (currently scheduled for July 2005).


Sectors Affected:


22131 Water Supply and Irrigation Systems


Agency Contact:
Crystal Rodgers
Environmental Protection Agency
Water
4607M
Washington, DC 20460
Phone: 202-564-5275
Fax: 202 564-3767
Email: [email protected]

Tracy Bone
Environmental Protection Agency
Water
4607M
Washington, DC 20460
Phone: 202-564-5257
Fax: 202 564-3767
Email: [email protected]
RIN: 2040-AA97
_______________________________________________________________________



EPA



138. NATIONAL PRIMARY DRINKING WATER REGULATIONS: LONG TERM 2 ENHANCED 
SURFACE WATER TREATMENT RULE
Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


This action may affect State, local or tribal governments and the 
private sector.


Legal Authority:


42 USC 300f; 42 USC 300g-1; 42 USC 300g-2; 42 USC 300g-3; 42 USC 300g-
4; 42 USC 300g-5; 42 USC 300g-6; 42 USC 300j-4; 42 USC 300j-9; 42 USC 
300j-11


CFR Citation:


40 CFR 141 to 142; 40 CFR 9


Legal Deadline:


None


Abstract:


The Long Term 2 Enhanced Surface Water Treatment Rule (LT2ESWTR) will 
control risk from microbial pathogens, specifically cryptosporidium, in 
drinking water. It is being developed simultaneously with the Stage 2 
Disinfectants and Disinfection Byproducts Rule (DBPR), which will 
address risk caused by the use of disinfectants in drinking water. This 
rule could affect all public water systems that use surface water as a 
source. Promulgating the LT2ESWTR and the Stage 2 DBPR as a paired 
rulemaking is necessary to ensure that adequate protection from 
microbial risk is maintained while EPA manages risk from disinfection 
byproducts. In developing the LT2ESWTR, EPA has analyzed a significant 
body of new survey data on microbial pathogens in source and finished 
waters, as well as data on parameters which could serve as indicators 
of microbial risk. This survey data, which was collected under the 
Information Collection Rule (ICR), Supplemental Surveys to the ICR, and 
additional research projects, has provided a substantially more 
comprehensive and complete picture of the occurrence of waterborne 
pathogens than was previously available. EPA has also used significant 
new data on the efficiency of treatment processes for the removal and 
inactivation of microorganisms, as well as new information on the 
pathogenicity of certain microbes, to determine effective regulatory 
requirements for controlling microbial risk. On March 30, 1999, EPA 
established a committee of stakeholders under the Federal Advisory 
Committee Act (FACA) to assist in the development of these rules; an 
agreement in principle was signed in September 2000 outlining the 
proposed rule options.


Statement of Need:


The purpose of the Long Term 2 Enhanced Surface Water Treatment Rule 
(LT2ESWTR) is to reduce health risks posed by Cryptosporidium and other 
microbial pathogens in drinking water. Cryptosporidium is a protozoa 
which causes cryptosporidiosis, a severe gastrointestinal disease. 
While cryptosporidiosis is generally self limiting in healthy 
individuals, it can be fatal for people with compromised immune 
systems. Cryptosporidium is removed to a degree by filtration but is 
highly resistant to conventional drinking water disinfectants, 
including chlorine and chloramines. EPA has recently collected a 
significant amount of data on occurrence of Cryptosporidium in drinking 
water sources through the Information Collection Rule (ICR) and ICR 
Supplemental Surveys. These data indicate that a subset of drinking 
water systems have an unacceptably high risk for Cryptosporidium in 
their treated water. The LT2ESWTR is intended to identify systems at 
high risk for Cryptosporidium through monitoring and prescribe an 
appropriate level of additional treatment. In addition, the LT2ESWTR 
will be promulgated simultaneously with the Stage 2 Disinfectants and 
Disinfection Byproducts Rule (DBPR). This will help to ensure that 
drinking water utilities do not compromise adequate microbial 
protection while they take steps to control DBPs.


Summary of Legal Basis:


Section 1412(b)(7)(A) of SDWA authorizes the Administrator to 
promulgate a national primary drinking water regulation that requires 
the use of a treatment technique in establishing a maximum contaminant 
level if the Administrator makes a finding that it is not feasible to 
ascertain the level of the contaminant. The MCLG for Cryptosporidium is 
zero and it is not feasible for public water systems to measure 
Cryptosporidium concentrations in treated water. Consequently, under 
Section 1412(b)(1)(A), the Administrator may establish a treatment 
technique for Cryptosporidium if this presents a meaningful opportunity 
for health risk reduction. Although the 1996 Amendments do not require 
EPA to finalize a Long Term 2 Enhanced Surface Water Treatment Rule 
concurrently with the Stage 2 Disinfectants and Disinfection Byproducts 
Rule, Congress did emphasize the importance of ensuring proper balance 
between microbial and DBP risks and, therefore, EPA believes it is 
important to finalize these rules together.


Alternatives:


EPA is considering various rule scenarios to reduce risk from 
Cryptosporidium. These scenarios include treatment requirements that 
would apply to all systems, such as requiring all conventional plants 
to achieve 2-log inactivation of Cryptosporidium. Alternative scenarios 
have involved assigning systems to bins based on mean Crypto source 
water concentrations. Additional treatment requirements would then 
depend on the bin to which a system was assigned. Issues associated 
with the binning approach include: amount of monitoring necessary to 
assign systems to bins, appropriate Crypto concentrations to demarcate 
bin boundaries, and appropriate level of additional treatment for a 
given bin.

[[Page 72846]]

EPA is exploring analyses that evaluate the impact of these issues on 
costs and benefits. EPA has also considered options to reduce the 
impact on small systems.


Anticipated Cost and Benefits:


EPA estimates that the LT2ESWTR, as proposed will have an annual cost 
of $73 to $111 million per year. The majority of people (approximately 
67 percent) are served by public water systems that use a surface water 
or ground water under the direct influence of surface water. Thus, a 
large number of people will benefit from the LT2ESWTR. EPA estimates 
that the proposed LT2ESWTR would prevent up to 1,020,000 cases of 
cryptsporidiosis annually with an economic benefit of up to $1.4 
billion. In addition, EPA has recently identified UV light as a 
technology that can achieve high levels of Cryptosporidium inactivation 
at relatively low cost.


Risks:


Approximately 67 percent of consumers are served by drinking water 
systems that use surface water sources or ground water under the direct 
influence of surface water. Survey data indicate that Cryptosporidium 
is prevalent in drinking water sources and current levels of treatment 
may not be adequate to control highly resistant pathogens like 
Cryptosporidium. Cryptosporidiosis is a potentially fatal disease in 
people with weak immune systems, such as infants, the elderly, people 
with AIDS, and people taking immune suppressing drugs like cancer and 
transplant patients. By requiring additional treatment for those 
systems with the highest concentrations of Cryptosporidium in their 
source waters, EPA expects to significantly reduce current risk.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            68 FR 47639                                    08/11/03
Final Action                                                   07/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


Federal, Local, State, Tribal


Federalism:


 This action may have federalism implications as defined in EO 13132.


Additional Information:


SAN 4341.


Sectors Affected:


22131 Water Supply and Irrigation Systems


Agency Contact:
Dan Schmelling
Environmental Protection Agency
Water
4607
Washington, DC 20460
Phone: 202-564-5281
Fax: 202 564-3767
Email: [email protected]

Thomas Grubbs
Environmental Protection Agency
Water
4607M
4607
Washington, DC 20460
Phone: 202-564-5262
Fax: 202 564-3767
Email: [email protected]
RIN: 2040-AD37
_______________________________________________________________________



EPA



139. NATIONAL PRIMARY DRINKING WATER REGULATIONS: STAGE 2 DISINFECTION 
BYPRODUCTS RULE
Priority:


Economically Significant


Unfunded Mandates:


This action may affect State, local or tribal governments and the 
private sector.


Legal Authority:


42 USC 300f; 42 USC 300g-2; 42 USC 300g-3; 42 USC 300g-4; 42 USC 300g-
5; 42 USC 300g-6; 42 USC 300j-4; 42 USC 300j-9; 42 USC 300j-11


CFR Citation:


40 CFR 141 to 142; 40 CFR 9


Legal Deadline:


Final, Statutory, July 14, 2003.


Abstract:


This Regulation, along with a Long Term 2 Enhanced Surface Water 
Treatment Rule (LT2ESWTR) that will be promulgated simultaneously, is 
intended to expand existing public health protections and address 
concerns about risk trade-offs between pathogens and disinfection 
byproducts. This rule could affect all public water systems that add a 
disinfectant to the drinking water during any part of the treatment 
process, although the impacts may be limited to community water systems 
(CWSs) and non-transient non-community water systems (NTNCWSs). 
Promulgating the LT2ESWTR and the Stage 2 DBPR as a paired rulemaking 
is necessary to ensure that adequate protection from microbial risk is 
maintained while EPA manages risk from disinfection byproducts. In 
developing the Stage 2 DBPR, EPA analyzed a significant body of new 
survey data on source water quality parameters, treatment data and 
disinfection byproduct occurrence. This survey data, which was 
collected under the Information Collection Rule (ICR), Supplemental 
Surveys to the ICR, and additional research projects, provide a 
substantially more comprehensive and complete picture of the occurrence 
of DBPs and microbiological pathogens than was previously available. 
EPA also used new information on the health effects of exposure to DBPs 
to determine effective regulatory requirements for controlling risk. On 
March 30, 1999, EPA reconvened a committee of stakeholders under the 
Federal Advisory Committee Act (FACA) to assist in the development of 
these rules; an Agreement in Principle was signed in September 2000 
outlining the proposed rule options.


Statement of Need:


The purpose of the Stage 2 Disinfectants/Disinfection Byproducts Rule 
(DBPR) is to reduce potential health risks posed by disinfection 
byproducts (DBPs). Certain DBPs have been shown in laboratory tests to 
be carcinogens or to cause adverse reproductive and developmental 
health effects. In addition, epidemiology studies have indicated that 
exposure to chlorinated water may increase the risk of bladder cancer, 
miscarriage, and certain developmental defects. The Stage 2 DBPR is 
designed to reduce peak events in DBP exposure in order to mitigate 
these potential health risks.


Summary of Legal Basis:


Section 1412(b)(2)(C) of SDWA, as amended in 1996, requires EPA to 
promulgate a Stage 2 Disinfectants/Disinfection Byproducts Rule no 
later than July 14, 2003. Although the 1996 Amendments do not require 
EPA to finalize a Long Term 2 Enhanced Surface Water Treatment Rule 
concurrently with the Stage 2 Disinfectants and Disinfection Byproducts 
Rule, Congress did emphasize the importance of ensuring proper balance 
between microbial and DBP risks and, therefore, EPA believes

[[Page 72847]]

it is important to finalize these rules together.


Alternatives:


EPA is considering various rule scenarios to achieve reductions in 
disinfection byproduct exposure. These alternatives include: decreasing 
the standard set in the Stage 1 DBPR (0.080 mg/L total trihalomethanes 
(TTHM) and 0.060 mg/L the sum of 5 haloacetic acids (HAA5)) by half and 
maintaining a running annual average compliance calculation; 
maintaining 80/60 TTHM/HAA5 standards but revising the compliance 
calculation to a stricter locational running annual average; setting 
the 80/60 TTHM/HAA5 standard as a never to be exceeded maximum; and 
revising the standard for bromate which is currently 0.010 mg/L. EPA 
has also considered options to reduce the impact on small systems.


Anticipated Cost and Benefits:


EPA estimates that the Stage 2 DBPR will have an annual economic impact 
of $59-65 million. Over 200 million people are served by public water 
systems that apply a disinfectant (e.g., chlorine) to water in order to 
provide protection against microbial contaminants and potentially 
exposed to DBPs. Thus, a large number of people will benefit from the 
Stage 2 DBPR.


Risks:


Over 200 million people are served by public water systems that apply a 
disinfectant (e.g., chlorine) to water in order to provide protection 
against microbial contaminants. Due to the large number of people 
exposed to DBPs, there is a substantial concern for any risks 
associated with DBPs that may impact public health. EPA estimates that 
the Stage 2 DBPR will decrease exposure to DBPs on average but more 
importantly, the rule will significantly reduce exposure to peak 
occurrences of DBPs.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            68 FR 49548                                    08/18/03
Final Action                                                   07/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


Federal, Local, State, Tribal


Federalism:


 This action may have federalism implications as defined in EO 13132.


Additional Information:


SAN 4342.


Sectors Affected:


22131 Water Supply and Irrigation Systems


Agency Contact:
Tom Grubbs
Environmental Protection Agency
Water
4607
Washington, DC 20460
Phone: 202 564-5262
Fax: 202 564-3767
Email: [email protected]

Stig Regli
Environmental Protection Agency
Water
4607M
Washington, DC 20460
Phone: 202 564-5270
Fax: 202 564-3767
Email: [email protected]
RIN: 2040-AD38
_______________________________________________________________________



EPA



140. MINIMIZING ADVERSE ENVIRONMENTAL IMPACT FROM COOLING WATER INTAKE 
STRUCTURES AT EXISTING FACILITIES UNDER SECTION 316(B) OF THE CLEAN 
WATER ACT, PHASE 3
Priority:


Other Significant


Unfunded Mandates:


This action may affect the private sector under PL 104-4.


Legal Authority:


33 USC 1311 CWA 301; 33 USC 1316 CWA 306; 33 USC 1326 CWA 316; 33 USC 
1361 CWA 501


CFR Citation:


40 CFR 9; 40 CFR 122; 40 CFR 123; 40 CFR 124; 40 CFR 125


Legal Deadline:


NPRM, Judicial, November 1, 2004.


Final, Judicial, June 1, 2006.


Abstract:


This rulemaking will affect existing facilities that use cooling water 
intake structures, and whose intake flow levels exceed a minimum 
threshold to be determined by EPA during this rulemaking. The proposed 
rule addresses all existing facilities if they meet the proposed 
threshold levels, including those in the following industries: (1) 
Electricity generating facilities not covered by Phase 2 regulations; 
(2) pulp and paper manufacturing facilities; (3) chemicals and allied 
products manufacturing facilities; (4) petroleum and coal products 
manufacturing facilities; and (5) primary metals manufacturing 
facilities. EPA also proposed regulations for new offshore and coastal 
oil and gas extraction facilities, which EPA excluded from the Phase I 
rule for other, land-based facilities. Section 316(b) of the Clean 
Water Act provides that any standard established pursuant to sections 
301 or 306 of the Clean Water Act and applicable to a point source 
shall require that the location, design, construction, and capacity of 
cooling water intake structures reflect the best technology available 
for minimizing adverse environmental impact. A primary purpose of this 
action is to minimize the impingement and entrainment of fish and other 
aquatic organisms by cooling water intake structures. Impingement 
occurs when fish and other aquatic life are trapped against cooling 
water intake structures. Entrainment occurs when aquatic organisms, 
eggs and larvae are drawn into a cooling system and then pumped back 
out, resulting in significant injury or mortality to the entrained 
organisms.


Statement of Need:


In the absence of national regulations, Permit Directors have regulated 
cooling water intake structures incompletely and inconsistently, 
especially with respect to the manufacturing sector. In some instances, 
permit issuance or reissuance has been significantly delayed or permit 
decisions from 20 or more years ago have not been reevaluated. 
Significant numbers of fish and other aquatic organisms may be cropped 
annually as a result of cooling water intake structures at a single 
large intake or through the cumulative impact at multiple small intakes 
on the same waterbody. By court order, EPA must propose and take final 
action on this regulation. This regulation may have substantial 
ecological benefits.


Summary of Legal Basis:


This action is required under an Amended Consent Decree in Riverkeeper 
Inc. et al. v. Whitman, 93 Civ. 0314 (AGS)(U.S. District Court, 
Southern District of New York, November 21, 2000).

[[Page 72848]]

Alternatives:


This analysis will cover various sizes and types of potentially 
regulated facilities. EPA is considering whether to regulate on a site-
specific, waterbody category, or national basis. EPA is also 
considering several flow thresholds, below which the regulation would 
not apply and permits would continue to be issued on a case-by-case 
basis by Permit Directors using their best professional judgment.


Anticipated Cost and Benefits:


Costs are yet to be determined, but are not expected to exceed $100 
million. While monetized use benefits are expected to be lower than 
monetized costs, a qualitative assessment of ecological benefits at 
several large facilities indicates the potential for additional 
benefits when intakes are controlled. Costs and benefits are generally 
expected to be smaller at facilities that use smaller amounts of 
cooling water.


Risks:


Cooling water intake structures may pose significant risks for aquatic 
ecosystems.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           11/00/04
Final Action                                                   06/00/06
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


Federal, Local, State, Tribal


Additional Information:


SAN No. 4543; Split from RIN 2040-AC34.


Sectors Affected:


312 Beverage and Tobacco Product Manufacturing; 325 Chemical 
Manufacturing; 61131 Colleges, Universities and Professional Schools; 
334 Computer and Electronic Product Manufacturing; 211111 Crude 
Petroleum and Natural Gas Extraction; 22111 Electric Power Generation; 
335 Electrical Equipment, Appliance and Component Manufacturing; 332 
Fabricated Metal Product Manufacturing; 311 Food Manufacturing; 333 
Machinery Manufacturing; 21 Mining; 211112 Natural Gas Liquid 
Extraction; 327 Nonmetallic Mineral Product Manufacturing; 322 Paper 
Manufacturing; 324 Petroleum and Coal Products Manufacturing; 326 
Plastics and Rubber Products Manufacturing; 331 Primary Metal 
Manufacturing; 22133 Steam and Air-Conditioning Supply; 313 Textile 
Mills; 336 Transportation Equipment Manufacturing; 321 Wood Product 
Manufacturing


Agency Contact:
Paul Shriner
Environmental Protection Agency
Water
4303T
Washington, DC 20460
Phone: 202-566-1076
Fax: 202 566-1053
Email: [email protected]

Martha Segall
Environmental Protection Agency
Water
4303T
Washington, DC 20460
Phone: 202-566-1041
Fax: 202 566-1053
Email: [email protected]
RIN: 2040-AD70
_______________________________________________________________________



EPA



141. CROSS-MEDIA ELECTRONIC REPORTING (ER) AND RECORDKEEPING RULE 
(CROMERRR)
Priority:


Other Significant


Legal Authority:


PL 104-13; PL 105-277


CFR Citation:


40 CFR 3 (New); 40 CFR 9 (Revision)


Legal Deadline:


None


Abstract:


As proposed, the Cross-Media Electronic Reporting (ER) and 
Recordkeeping Rule (CROMERRR) was intended to provide a uniform legal 
framework for paperless electronic reporting and recordkeeping, 
including electronic signature/certification, across EPA's 
environmental compliance programs. Based on public comment, however, 
EPA now plans to focus on finalizing the electronic reporting 
components of proposed CROMERRR, and to defer further action on the 
electronic recordkeeping components until a later time. Under current 
plans, the final electronic reporting (ER) rule will address electronic 
reporting by companies regulated under all of EPA's programs: air, 
water, pesticides, toxic substances, wastes, and emergency response. 
The final rule would remove existing regulatory obstacles to electronic 
reporting, and it would set requirements for companies choosing to 
report electronically. In addition, the rule would set the conditions 
for allowing electronic reporting under State, tribal or local 
environmental programs that operate under EPA authorization. The final 
ER rule is intended to make electronic reporting as simple, efficient, 
and cost-effective as possible for regulated companies, while ensuring 
that a transition from paper to electronic reporting does not 
compromise EPA's compliance and enforcement programs. Consequently, the 
Agency's strategy is to impose as few specific requirements as 
possible, and to keep those requirements neutral with respect to 
technology, so the rule will pose no obstacles to adopting new 
technologies as they emerge. To ensure that authorized programs at the 
State, tribal, and local levels meet EPA's electronic reporting goals, 
the final ER rule would specify a set of criteria that these programs 
must satisfy as they initiate electronic reporting. In response to 
public comments, EPA is also planning to include provisions for a 
streamlined process for EPA to review and approve authorized program 
revisions or modifications to allow electronic reporting.


Statement of Need:


EPA is required by the Government Paperwork Elimination Act (GPEA) of 
1998 to make the option of electronic reporting and recordkeeping 
available, where practicable, to its regulated community by 2003. To 
meet this deadline and comply with GPEA, EPA believes that it needs to 
put a new legal framework in place for electronic reporting. A final ER 
rule would provide for this legal framework by: (1) Removing legal 
obstacles to electronic reporting posed by explicit references to paper 
and paper-based processes in EPA regulations; and (2) assuring that 
electronically submitted documents will have the same legal and 
evidentiary force as their paper counterparts, whether the submission 
is directly to EPA or under an EPA-authorized program.


Summary of Legal Basis:


Government Paperwork Elimination Act (GPEA) of 1998. GPEA requires 
Federal agencies to provide, where practicable, the option of 
electronic reporting and

[[Page 72849]]

recordkeeping to their regulated communities by 2003.


Alternatives:


One alternative to an EPA cross-media ER rule that applies to most 
compliance reports under 40 CFR would be individual rulemakings by each 
of the program offices. EPA's past experience with program-by-program 
ER rulemakings has demonstrated that such an approach would be more 
costly and take much longer to complete. EPA also considered the use of 
guidance instead of rulemaking, but rejected this alternative based 
principally on a concern that program enforceability depends greatly on 
the ability to mandate a certain level of functionality for systems 
that will be used to receive electronic reports and other electronic 
documents.


Anticipated Cost and Benefits:


EPA received a number of comments on the assumptions used to generate 
the cost and benefit estimates for the electronic reporting components 
of proposed CROMERRR; based on this feedback, EPA decided to develop a 
new analysis of the costs and benefits for the final ER rule. As a part 
of this effort, EPA has conducted extensive follow-up interviews with 
commenters, reevaluated existing sources of information, and conducted 
new market research on ER technologies. The results have led EPA to 
revise certain assumptions associated with the CROMERRR proposal that 
bear on the ER rule's costs and benefits to regulated entities and to 
Federal, State, and local governments. Proposed CROMERRR had assumed 
that the costs and benefits of electronic reporting under authorized 
programs could be attributed entirely to the rule. EPA has since 
learned that a significant number of electronic reporting systems 
already operate under such programs; correspondingly, the ER rule 
cannot take credit for the costs and benefits of electronic reporting 
in such cases, but only for the costs or benefits that result from 
changes that occur as a result of the rule. With respect to regulated 
entities, EPA has had to adjust a number of assumptions associated with 
electronic signature requirements, including those related to the 
number of registered signature-holders at each facility, and the 
availability of acceptable alternatives to Public Key Infrastructure-
based electronic signature approaches in many instances. EPA is also 
refining its estimate of the number of potentially affected regulated 
entities. With respect to the Federal government, EPA has reconsidered 
the general costs and benefits of electronic reporting based on 
experience operating EPA's Central Data Exchange and other EPA systems, 
and based also on an in-depth analysis of business processes and 
associated costs for several major EPA programs implementing electronic 
reporting. Based on these and other revisions to our assumptions, EPA 
has developed preliminary new cost/benefit results. They indicate that 
regulated entities and State and local government agencies will incur 
modest net costs from the ER rule; EPA will experience modest net 
benefits. Qualitative benefits of electronic reporting were also 
identified, including: enhanced data quality, faster public access to 
submitted data, better tracking of compliance submissions, and 
opportunities for re-engineering current paper processes. Finally, 
comments on the CROMERRR also indicated the need for substantial 
reworking of the cost and benefit analyses with respect to the 
electronic recordkeeping components of the proposal. Given EPA's 
current focus on electronic reporting, EPA will defer additional 
economic analysis in this area until the Agency resumes work on 
electronic recordkeeping.


Risks:


The risks are undetermined.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            66 FR 46162                                    08/31/01
Final Action                                                   12/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, Local, State, Tribal


Federalism:


 This action may have federalism implications as defined in EO 13132.


Additional Information:


SAN No. 4270; Formerly listed as RIN 2020-AA41.


Agency Contact:
Evi Huffer
Environmental Protection Agency
Office of Environmental Information
2823T
Washington, DC 20460
Phone: 202-566-1697
Fax: 202 566-1684
Email: [email protected]

David Schwarz
Environmental Protection Agency
Office of Environmental Information
2823T
Washington, DC 20460
Phone: 202-566-1704
Fax: 202 566-1684
Email: [email protected]
RIN: 2025-AA07
BILLING CODE 6560-50-S

[[Page 72850]]




EQUAL EMPLOYMENT OPPORTUNITY COMMISSION (EEOC)



Statement of Regulatory and Deregulatory Priorities
 The mission of the Equal Employment Opportunity Commission (EEOC, 
Commission, or Agency) is to ensure equality of opportunity in 
employment by vigorously enforcing six Federal statutes. These statutes 
are: Title VII of the Civil Rights Act of 1964, as amended (prohibits 
employment discrimination on the basis of race, color, sex, religion, 
or national origin); the Equal Pay Act of 1963, as amended; the Age 
Discrimination in Employment Act of 1967 (ADEA), as amended; title I of 
the Americans with Disabilities Act of 1990, as amended, and sections 
501 and 505 of the Rehabilitation Act of 1973, as amended (disability); 
and the Government Employee Rights Act of 1991, which extends 
protections against employment discrimination to certain employees who 
were not previously covered.
 The significant action of a regulatory nature now under consideration 
is amending regulations governing age discrimination in employment to 
exempt from the prohibitions of the Age Discrimination in Employment 
Act (ADEA) the practice of altering, reducing, or eliminating employer-
sponsored retiree health benefits when retirees become eligible for 
Medicare or comparable State retiree health benefits. This rule will 
ensure that the application of the ADEA does not discourage employers 
from providing health benefits to their retirees. The Commission does 
not believe that the proposed exemption will have a significant impact 
on small business entities under the Regulatory Flexibility Act because 
it imposes no economic or reporting burdens on such firms.
Consistent with section 4(c) of Executive Order 12866, this statement 
was reviewed and approved by the Chair of the Agency. The statement has 
not been reviewed or approved by the other members of the Commission.
_______________________________________________________________________



EEOC

                              -----------

                            FINAL RULE STAGE

                              -----------




142. COORDINATION OF RETIREE HEALTH BENEFITS WITH MEDICARE AND STATE 
HEALTH BENEFITS
Priority:


Other Significant


Legal Authority:


29 USC 628


CFR Citation:


29 CFR 1625


Legal Deadline:


None


Abstract:


The Commission proposes to exempt from the prohibitions of the Age 
Discrimination in Employment Act of 1967, 29 U.S.C. 621 et seq. (ADEA 
or Act), the practice of altering, reducing, or eliminating employer-
sponsored retiree health benefits when retirees become eligible for 
Medicare or comparable State retiree health benefits.


Statement of Need:


In August 2001, the Commission announced that it would consider the 
relationship between the ADEA and employer-sponsored retiree health 
benefit plans that alter, reduce, or eliminate benefits upon 
eligibility for Medicare or a comparable State-sponsored retiree health 
benefits program. There has been a decline in the number of employers 
providing retiree health benefits over the last 10 years. Various 
factors have contributed to this erosion, including the increased cost 
of health care coverage, an increased demand for such coverage as large 
numbers of workers near retirement age, and changes in the way 
accounting rules treat the long-term costs of providing retiree health 
benefits. Another factor has been employer concern about the potential 
application of the ADEA to employer-sponsored retiree health benefits. 
The Commission is proposing a narrowly drawn ADEA exemption that 
permits the practice of coordinating employer-provided retiree health 
coverage with eligibility for Medicare or a State-sponsored retiree 
health benefits program, so that the ADEA does not discourage employers 
from providing, or continuing to provide, health benefits to their 
retirees.


Summary of Legal Basis:


Pursuant to section 9 of the ADEA, the Commission is authorized to 
establish reasonable exemptions to and from any or all provisions of 
the Act as it may find necessary and proper in the public interest.


Alternatives:


The Commission considered various alternatives in developing this 
proposal. The Commission will consider all alternatives offered by the 
public commenters.


Anticipated Cost and Benefits:


The Commission recognizes that while employers are under no legal 
obligation to offer retiree health benefits, some employers choose to 
do so in order to maintain a competitive advantage in the marketplace, 
using these and other benefits to attract and retain the best talent 
available to work for their organizations. The proposed rule will 
ensure that the application of the ADEA does not discourage employers 
from providing, or continuing to provide, health benefits to their 
retirees who otherwise would have to obtain such coverage in the 
private individual marketplace at significant personal expense. The 
Commission believes that it is in the best interest of both employers 
and employees for the Commission to pursue a policy that permits 
employers to offer these benefits to the greatest extent possible. It 
is not anticipated that the proposal will result in increased costs.


Risks:


The proposed regulatory action will reduce the risks of liability for 
noncompliance with the statute by exempting certain employer practices 
from regulation. This proposal does not address risks to public safety 
or the environment.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            68 FR 41542                                    07/14/03
NPRM Comment Period End                                        09/12/03
Final Action                                                   12/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, Local, State

[[Page 72851]]

Agency Contact:
Dianna B. Johnston
Assistant Legal Counsel, Office of Legal Counsel
Equal Employment Opportunity Commission
1801 L Street NW
Washington, DC 20507
Phone: 202 663-4638
TDD Phone: 202 663-7026
Fax: 202 663-4639
Email: [email protected]
RIN: 3046-AA72
BILLING CODE 6570-01-S

[[Page 72852]]




GENERAL SERVICES ADMINISTRATION (GSA)



Statement of Regulatory and Deregulatory Priorities
 The General Services Administration (GSA) establishes Governmentwide 
policy for construction and operation of buildings, procurement and 
distribution of supplies, travel and transportation, acquisition, 
electronic commerce, management of advisory committees, and utilization 
and disposal of real and personal property.
 GSA's fiscal year 2005 regulatory priority is to complete conversion 
of the Federal Property Management Regulations to the Federal 
Management Regulation (FMR).
 GSA is writing the FMR so that its contents are consistent and 
sensible and limit the regulatory burden placed on Government officials 
and the public. GSA has adopted a question and answer, plain language 
format for its regulations to make them easier to read and understand. 
Non-regulatory guidance is being moved into other, less formal 
publications such as customer service guides.
 As necessary, GSA will prepare its regulations so that they address 
national health and security concerns, particularly those created as a 
result of the events of September 11, 2001.
BILLING CODE 6840-34-S

[[Page 72853]]




NATIONAL AERONAUTICS AND SPACE ADMINISTRATION (NASA)



Statement of Regulatory Priorities
 The National Aeronautics and Space Administration (NASA) was 
established by the National Aeronautics and Space Act of 1958 (the 
Act), 42 United States Code (U.S.C.) 2451 et seq., which laid the 
foundation for NASA's mission. The Act authorizes NASA, among other 
things, to conduct space activities devoted to peaceful purposes for 
the benefit of humankind; to preserve the leadership of the United 
States in aeronautics and space science and technology; and to expand 
knowledge of the Earth and space. To carry out this mission, NASA is 
authorized to conduct research for the solution of problems of flight 
within and outside the Earth's atmosphere; to develop, construct, test, 
and operate aeronautical and space vehicles for research purposes; to 
operate space transportation systems, including the Space Shuttle and 
the International Space Station; and to perform such other activities 
as may be required for the exploration of space. NASA conducts 
activities required for the exploration of space with human-tended, 
robotic, and expendable vehicles and arranges for the most effective 
utilization of the scientific and engineering resources of the United 
States with other nations engaged in aeronautical and space activities 
for peaceful purposes.
 NASA's mission, as documented in its 2003 Strategic Plan, is to 
understand and protect our home planet, to explore the universe and 
search for life, and to inspire the generation of explorers as only 
NASA can.
 Our mission is driven by science, exploration, and discovery, and it 
will be carried out with a firm commitment to fiscal responsibility. We 
will study climate change and the natural and human-induced hazards to 
Earth's ecosystem. We will help to counter the threat of international 
terrorism by developing technologies that can improve the security and 
safety of our air transportation system. We will lead the world into a 
new understanding of our planet, our solar system, and the universe 
around us, and in so doing, we will begin to understand whether life 
may have developed elsewhere in the cosmos.
 The following are narrative descriptions of the most important 
regulations being planned for publication in the Federal Register 
during fiscal year (FY) 2005.
 The Federal Acquisition Regulation (FAR), 48 CFR chapter 1, contains 
procurement regulations that apply to NASA and other Federal agencies. 
NASA implements and supplements FAR requirements through the NASA FAR 
Supplement (NFS), 48 CFR chapter 18. Major revisions are not expected 
in FY 2005, except to conform to FAR changes that are currently being 
promulgated in part 27, Patents, Data, and Copyrights; part 45, 
Government Property; and part 47, Transportation. In a continuing 
effort to keep the NFS current with NASA initiatives and Federal 
procurement policy, minor revisions to the NFS will be published.
 To reduce the time and cost spent by the Agency and our industry 
partners in the procurement of basic and applied research under 
cooperative agreements, NASA is focusing on streamlining our processes. 
To go forward in this effort, policy and guidance associated with the 
generation and review of Cooperative Agreements Notices (CAN) is being 
considered. Additionally, changes necessary for implementing a common 
format for grant announcements and addressing other internal management 
practices will be made.
NASA is continuing consideration of revisions to the cross-waiver of 
liability regulation at 14 CFR part 1266. Specifically, NASA is 
considering implementation of the cross-waiver of liability provision 
of the intergovernmental agreement of the International Space Station 
and refinement and clarification of contractual cross-waivers in NASA 
agreements involving launch services.
BILLING CODE 7510-13-S

[[Page 72854]]




NATIONAL ARCHIVES AND RECORDS ADMINISTRATION (NARA)



Statement of Regulatory Priorities
Overview
The National Archives and Records Administration (NARA) issues 
regulations directed to other Federal agencies and to the public. 
Records management regulations directed to Federal agencies concern the 
proper management and disposition of Federal records. Through the 
Information Security Oversight Office (ISOO), NARA also issues 
Governmentwide regulations concerning information security 
classification and declassification programs. NARA regulations directed 
to the public address access to and use of our historically valuable 
holdings, including archives, donated historical materials, Nixon 
Presidential materials, and Presidential records. NARA also issues 
regulations relating to the National Historical Publications and 
Records Commission (NHPRC) grant programs.
 NARA has four regulatory priorities for fiscal year 2005. The first, 
included in The Regulatory Plan, is to revise and update our records 
management regulations in 36 CFR ch. XII, subchapter B. We began work 
on this priority in fiscal year 2004 with a proposal for a new 
organizational framework for the records management regulations to make 
them easier to use. We will be issuing the revised regulations in 
stages. We are issuing certain priority revisions relating to records 
scheduling and disposition in advance of the overall subchapter B 
revision. This regulatory activity is part of a major NARA initiative 
to review and redesign our records management program that started in 
2000.
The second priority is to complete the revision of our records center 
facility standards regulation in 36 CFR part 1228, subpart K. This 
regulation affects small businesses and is discussed in greater detail 
in the following section.
Our third priority regulatory action is reviewing and revising our 
records declassification regulation in 36 CFR part 1260 to reflect 
changes in the Executive Order governing declassification of national 
security classified information (E.O. 12958, as amended, Classified 
National Security Information). Our regulations in part 1260 establish 
procedures for the automatic declassification of records in NARA's 
legal custody and revise requirements for reclassification of 
information as provided for in the Executive Order. NARA serves the 
public and Federal agencies by specifying the declassification process 
we use.
Our fourth priority regulatory action is reviewing and updating our 
NHPRC grants program regulations in 36 CFR part 1206. The NHPRC grants 
program participates in the Grants.gov eGovernment Initiative, and our 
review will ensure that the regulations reflect that participation. The 
NHPRC makes grants to preserve and to deliver historical records for 
use by the American people. The Commission each year receives over 150 
applications requesting over $15 million of which less than $10 million 
is available to award.
NARA does not have any planned regulatory actions that relate to the 
events of September 11, 2001.
Regulations of Particular Concern to Small Businesses
NARA's regulation specifying facility standards for records storage 
facilities that house Federal records (RIN 3095-AA81) has been 
identified as being of particular concern to small businesses. The 
current regulation went into effect in 2000 and was among the public 
reform nominations in the Office of Management and Budget's (OMB) 2003 
Report to Congress on the Costs and Benefits of Regulations. OMB 
referred this regulation to NARA for evaluation. After reviewing the 
regulation and extensive discussions with the records center industry 
association to which many small business records centers belong, NARA 
issued a proposed rule on September 7, 2004, that will still ensure 
protection of Federal records while reducing the burden on records 
centers that are small businesses.
_______________________________________________________________________



NARA

                              -----------

                          PROPOSED RULE STAGE

                              -----------




143. FEDERAL RECORDS MANAGEMENT
Priority:


Other Significant


Legal Authority:


44 USC 2104(a); 44 USC ch 21; 44 USC ch 29; 44 USC ch 33


CFR Citation:


36 CFR 1220 to 1238


Legal Deadline:


None


Abstract:


As part of its initiative to redesign Federal records management, NARA 
is revising its records management regulations in 36 CFR ch. XII, 
subchapter B to ensure that the regulations are appropriate, effective, 
and clear. During fiscal year 2005, we will publish several rules 
relating to the redesign.


Statement of Need:


NARA's records management program was developed in the 20th century in 
a paper environment. This program has not kept up with a Federal 
Government that creates and uses most of its records electronically. 
Today's Federal records environment requires different management 
strategies and techniques.


The revision of NARA's records disposition policies, processes, and 
tools is identified in our Strategic Plan as a key Strategy to meet the 
primary goal that ``essential evidence will be created, identified, 
appropriately scheduled, and managed for as long as needed`` Without 
effective records management, records needed to document citizens 
rights, actions for which Federal officials are responsible, and the 
historical experience of our Nation will be at risk of loss, 
deterioration, or destruction.


Summary of Legal Basis:


Under the Federal Records Act, the Archivist of the United States is 
responsible for: 1) providing guidance and assistance to Federal 
agencies to ensure adequate and proper documentation of the policies 
and transactions of the Federal Government and ensuring proper records 
disposition (44 U.S.C. 2904); 2) approving the disposition of Federal 
records (44 U.S.C. ch. 33); and 3) preserving and making available the 
Federal records of continuing value that have been transferred to the 
National Archives of the United States (44 U.S.C. ch. 21).


The Federal Records Act also makes the heads of Federal agencies 
responsible for making and preserving records containing adequate and 
proper documentation of the organization, functions, policies, 
decisions, procedures, and essential transactions of the agency and is 
designed to furnish the information necessary to protect the legal and 
financial rights of the Government and of persons directly affected by 
the agency's activities (44 U.S.C. 3101). Agency heads must also

[[Page 72855]]

have an active, continuing records management program (44 U.S.C. 3102).


Alternatives:


None.


Anticipated Cost and Benefits:


The revision of NARA's records disposition policies and processes, of 
which this regulation review is a part, is intended to reduce the 
burden on agencies and NARA in the area of records disposition 
activities.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Begin Review                                                   09/17/02
ANPRM           69 FR 12100                                    03/15/04
ANPRM Comment Period End                                       05/14/04
NPRM                                                           11/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal


URL For More Information:
www.archives.gov/records--management/initiatives/strategic--
directions.html
URL For Public Comments:
www.regulations.gov
Agency Contact:
Nancy Allard
Regulatory Contact
National Archives and Records Administration
Room 4100, NPOL
8601 Adelphi Road
College Park, MD 20740-6001
Phone: 301 837-1850
Fax: 301 837-0319
Email: [email protected]
Related RIN: Related to 3095-AB05, Related to 3095-AB41, Related to 
3095-AB43, Related to 3095-AB39
RIN: 3095-AB16
BILLING CODE 7515-01-S

[[Page 72856]]




OFFICE OF PERSONNEL MANAGEMENT (OPM)



Statement of Regulatory Priorities
 The Office of Personnel Management (OPM) is the human resources and 
personnel manager for the President and the Federal Government. The 
primary focus of OPM's regulatory efforts in the coming year will 
continue to be the modernization and improvement of human resources 
management to support the President's goal of creating a Government 
that is citizen-centered, results-oriented and market-based. To this 
end, OPM's primary regulatory objective is to implement improvements to 
human resources management that will enable the Federal Government to 
recruit, manage, develop, and retain the high-quality, diverse 
workforce that departments and agencies require to carry out their 
respective missions.
 The President's Management Agenda recognizes the critical role that 
human resources management must play in reforming Government by 
identifying the Strategic Management of Human Capital as the first of 
its five core Governmentwide initiatives. OPM is the managing partner 
on this Presidential initiative and has aggressively implemented a 
program to assist other agencies in achieving success in this area 
through aligning human resources management practices with agency 
missions and objectives. OPM will implement this initiative by way of 
collaboration, coordination, and regulation as necessary and 
appropriate during the coming year.
Department of Homeland Security
 The Homeland Security Act of 2002 authorized the creation of the 
Department of Homeland Security (DHS) through the combination of 
components of 22 other departments and agencies. In addition, the Act 
granted the President flexibility in the management of the Department's 
human resources (HR). OPM has been working with DHS and stakeholders 
for 18 months to design a new HR system in the areas of pay, 
performance management, labor management relations, adverse actions and 
appeals, and to issue enabling regulations that are responsive to the 
critical needs of the Department. We anticipate that final joint DHS/
OPM regulations establishing a new HR system will be issued in early 
fiscal year 2005.
National Security Personnel System
 The 2004 National Defense Authorization Act (NDAA) authorizes the 
creation of a National Security Personnel System (NSPS) at the 
Department of Defense (DoD). OPM has collaborated extensively with DoD 
to identify the regulatory requirements needed to establish a flexible 
and contemporary human resources management system as called for in the 
statute. The NSPS must be fair and credible, adhere to merit 
principles, honor veterans' preference, protect against prohibited 
personnel practices, and include a performance management system that 
incorporates pay for performance. In addition, the Act permits the 
establishment of a new labor relations system and a new employee 
appeals process, and grants flexibilities in recruitment and assignment 
actions and in the adjustment of overall agency staff. The NSPS is 
vital to DoD's national security mission and will remain a regulatory 
priority for OPM in the year ahead.
Compensation Reform
 OPM continues to study Governmentwide compensation reform and to 
gather information from stakeholders following the publication of OPM 
Director Kay Coles James' white paper on Federal compensation reform: 
``A Fresh Start for Federal Pay: The Case for Modernization.'' In 
addition, because compensation reform is a necessary element of 
improving the management of human capital?a central goal of the 
President's Management Agenda?OPM anticipates making promulgation of 
compensation reform regulations a priority in 2005, including the final 
regulations necessary to implement the SES pay for performance system, 
which was authorized under NDAA. OPM will also proceed with 
promulgating regulations to implement the provisions of the Human 
Capital Performance Fund, which was authorized under NDAA as well.
e-Government
 OPM has been designated as the managing partner on 5 of the 24 e-
Government initiatives in the President's Management Agenda. 
Specifically, OPM is the managing partner for Recruitment One Stop, e-
Clearance, e-Training, e-Payroll, and e-Enterprise HR Integration (e-
EHRI). These initiatives will require promulgation of new or modified 
regulations. In addition, OPM has been designated the managing partner 
of the Human Resources Line of Business (HR LOB). The objective of HR 
LOB is to create a framework for a Governmentwide, modern, cost 
effective, standardized, and interoperable Human Resources (HR) 
solution that provides common core functionality and maximizes 
automation of processes to support the strategic management of human 
capital. The current suite of e-Government initiatives managed by OPM 
will be transitioned and integrated into the HR LOB. This initiative 
will also require promulgation of new or modified regulations in 2005.
No FEAR Regulations
 In July 2003, the President delegated responsibility for promulgating 
regulations pursuant to title II of the Notification and Federal 
Employee Antidiscrimination and Retaliation Act of 2002 to OPM. The 
provisions of title II relate to reimbursement of the Treasury 
Department's judgment fund, notice and training for applicants and 
employees, and reporting requirements by agencies. Regulations 
concerning reimbursement of the judgment fund were promulgated on an 
interim final basis on January 22, 2004. In the coming year, working 
with the EEOC and Office of Special Counsel, OPM will promulgate 
regulations for the remaining provisions of title II of the Act.
Human Resources (HR) Flexibilities
 In 2003, OPM issued interim regulations to implement five new HR 
authorities enacted in the Chief Human Capital Officers Act (CHCO Act, 
title XIII of the Homeland Security Act). These included Voluntary 
Separation Incentive Program regulations that provided agencies with 
Governmentwide buyout authority. Upon OPM approval, agencies may use 
this authority as an important workforce reshaping tool in support of 
their human capital needs. OPM also provided agencies with four 
additional flexibilities. These new authorities provide agencies with: 
(1) increased flexibility in assessing applicants using alternative 
(category-based) rating and selection procedures; (2) the ability to 
select qualified candidates for competitive service positions using 
direct-hire procedures; (3) authority to pay or reimburse academic 
degree training costs from appropriated or other available funds and 
increased flexibility in academic degree training to address agency-
specific human capital objectives; and (4) revised voluntary early 
retirement authority criteria to address reshaping and restructuring 
issues. These authorities provide agencies with additional tools to 
recruit, retain, and reshape their workforce to meet critical mission 
goals and objectives. These interim regulations

[[Page 72857]]

allowed agencies immediate access to these new tools while 
simultaneously soliciting comments on potential program improvements. 
OPM is currently reviewing the comments received and will publish final 
regulations during the coming year.
Human Capital Management
 The CHCO Act also established a new chapter 14, Agency Chief Human 
Capital Officers, within title 5, U.S. Code, as well as a requirement 
for OPM to establish by regulation systems for assessing the management 
of human capital in Federal agencies. Provisions of the NDAA 
established a related requirement for agencies to conduct annual 
employee surveys under regulations issued by OPM. In the coming year, 
OPM will be addressing these and related general human capital 
management requirements through implementing regulations.
BILLING CODE 6325-44-S

[[Page 72858]]




PENSION BENEFIT GUARANTY CORPORATION (PBGC)



Statement of Regulatory and Deregulatory Priorities
PBGC Insurance Programs
 The Pension Benefit Guaranty Corporation (PBGC) administers two 
insurance programs for private defined benefit plans under title IV of 
the Employee Retirement Income Security Act of 1974 (ERISA): A single-
employer plan termination insurance program and a multiemployer plan 
insolvency insurance program. The PBGC protects the pensions of over 44 
million working men and women in about 31,000 private defined benefit 
plans, including about 1,600 multiemployer plans.
 The PBGC receives no funds from general tax revenues. Operations are 
financed by insurance premiums, investment income, assets from pension 
plans trusteed by the PBGC, and recoveries from the companies formerly 
responsible for the trusteed plans.
 To carry out these functions, the PBGC must issue regulations 
interpreting such matters as the termination process, establishment of 
procedures for the payment of premiums, and assessment and collection 
of employer liability.
Single-Employer Program
 Under the single-employer program, the PBGC pays guaranteed and 
certain other pension benefits to participants and beneficiaries if 
their plan terminates with insufficient assets (distress and 
involuntary terminations). At the end of fiscal year 2003, the PBGC was 
trustee of about 3,300 plans and paid $2.5 billion in benefits to about 
459,000 people during 2003. Another 475,000 people will receive 
benefits when they retire in the future.
 Most terminating single-employer plans terminate with sufficient 
assets to pay all benefits. The PBGC has administrative responsibility 
for these terminations (standard terminations), but its role is limited 
to seeing that proper procedures are followed and participants and 
beneficiaries receive their plan benefits.
 The private defined benefit pension system has been under pressure for 
some time and has become a matter of public concern. In July 2003, the 
Administration issued an initial set of legislative proposals that 
would: (1) Improve the accuracy of pension liability measurements by 
modifying the discount interest rate; (2) increase the transparency of 
pension plan information and make public pension underfunding 
information provided to PBGC for companies with over $50 million in 
underfunding; and (3) require immediate funding of accruals, benefit 
increases, and lump sum payments in certain situations involving a 
financially distressed company and fix PBGC's guarantee limit as of the 
date a plan sponsor files for bankruptcy. In addition, the 
Administration is developing comprehensive pension reform proposals to 
improve retirement security for workers and to strengthen the pension 
insurance system.
Multiemployer Program
 The multiemployer program (which covers about 9.7 million workers and 
retirees in about 1,600 insured plans) is funded and administered 
separately from the single-employer program and differs in several 
significant ways. The multiemployer program covers only collectively 
bargained plans involving more than one unrelated employer. The PBGC 
provides financial assistance (in the form of a loan) to the plan if 
the plan is unable to pay benefits at the guaranteed level. Guaranteed 
benefits are less than single-employer guaranteed benefits. PBGC 
financial assistance occurs infrequently.
Objectives and Priorities
 PBGC regulatory objectives and priorities are developed in the context 
of the statutory purposes of title IV: (1) To encourage continuation 
and maintenance of voluntary private pension plans, (2) to provide for 
the timely and uninterrupted payment of pension benefits to 
participants and beneficiaries, and (3) to maintain the premiums that 
support the insurance programs at the lowest possible levels consistent 
with carrying out the PBGC's statutory obligations (ERISA section 
4002(a)). In addition, PBGC receives no taxpayer monies. It is a self-
financing government corporation. Principal revenue sources are 
premiums paid by plan sponsors and income generated by assets held by 
PBGC.
 The PBGC implements its statutory purposes by developing regulations 
designed: (1) To assure the security of the pension benefits of 
workers, retirees, and beneficiaries; (2) to improve services to 
participants; (3) to ensure that the statutory provisions designed to 
minimize losses for participants and PBGC in the event of plan 
termination are effectively implemented; (4) to encourage the 
continuation and maintenance of voluntary private pension plans; (5) to 
facilitate the collection of monies owed to plans and to the PBGC, 
while keeping the related costs and burdens as low as possible; (6) to 
simplify the termination process; and (7) to minimize reporting and 
other burdens.
Regulatory Priorities
 The PBGC regulatory priorities are focused on changes to improve 
transparency and to simplify filing with PBGC by increasing use of 
electronic filing. PBGC policymaking gives consideration to the special 
needs and concerns of small business.
Improve Transparency of Information
 PBGC is developing a regulatory package to improve transparency of 
information to enable plan participants, investors, and PBGC to make 
more informed decisions and to encourage more responsible funding of 
pension plans. The transparency proposals relate to three areas--plan 
actuarial information and employer financial information that is 
required of certain employers with large amounts of pension 
underfunding, notice to PBGC that is required for certain events that 
threaten plan funding, and funding information that is required to be 
provided in an annual Participant Notice by certain underfunded plans. 
In addition, in order to improve compliance with the Participant Notice 
requirements, PBGC, in May 2004, published a Notice in the Federal 
Register providing a voluntary correction program designed to encourage 
correction of recent compliance failures and to facilitate future 
compliance. At the same time, PBGC proposed a new Participant Notice 
penalty policy that will be used for future violations of the 
Participant Notice requirements.
Simplify Filing by Increasing Use of Electronic Filing
 The PBGC introduced optional electronic filing of premiums in 2004 
with an online filing system that employs PBGC software. PBGC will be 
specifying a common data standard so that private vendors can develop 
software that filers can use in lieu of PBGC software. PBGC will be 
moving toward requiring electronic premium filing for all plans, which 
will simplify their paperwork, improve accuracy of PBGC's premium 
records and database, and enable more prompt payment of premium 
refunds. In addition, electronic filing will be required for plan 
actuarial and employer financial information reported to PBGC by 
employers with large amounts of pension underfunding. Electronic filing 
will reduce the filing burden, improve

[[Page 72859]]

accuracy, and better enable PBGC to monitor and manage risks posed by 
these plans.
Relief for Small Businesses
 A large percentage of the plans insured by the PBGC are small or 
maintained by small employers. The PBGC takes the special needs and 
concerns of small entities into account in developing its regulatory 
policies. For example, the May 2004 proposed revisions to the penalty 
structure for failure to comply with the Participant Notice 
requirements scale down the penalty rate based on the number of plan 
participants.
 The PBGC will continue to review its regulations to look for further 
simplification opportunities. The PBGC's regulatory plan for October 1, 
2004, to September 30, 2005, consists of two significant regulatory 
actions.
_______________________________________________________________________



PBGC

                              -----------

                          PROPOSED RULE STAGE

                              -----------




144. ALLOCATION OF ASSETS IN SINGLE-EMPLOYER PLANS; VALUATION OF 
BENEFITS AND ASSETS
Priority:


Other Significant


Legal Authority:


29 USC 1302(b)(3); 29 USC 1341; 29 USC 1301(a); 29 USC 1344; 29 USC 
1362


CFR Citation:


29 CFR 4044, subpart B


Legal Deadline:


None


Abstract:


The PBGC is considering amending its benefit valuation and asset 
allocation regulations by adopting more current mortality tables and 
otherwise simplifying and improving its valuation assumptions and 
methods.


Statement of Need:


The PBGC's regulations prescribe rules for valuing a terminating plan's 
benefits for several purposes, including (1) determining employer 
liability and (2) allocating assets to determine benefit entitlements. 
The PBGC's interest assumption for valuing benefits, when combined with 
the PBGC's mortality assumption, is intended to reflect the market 
price of single-premium, nonparticipating group annuity contracts for 
terminating plans. In developing its interest assumptions, the PBGC 
uses data from surveys conducted by the American Council of Life 
Insurers. The PBGC currently uses a mortality assumption based on the 
1983 Group Annuity Mortality Table in its benefit valuation and asset 
allocation regulations (29 CFR parts 4044 and 4281).


In May 1995, the Society of Actuaries Group Annuity Valuation Table 
Task Force issued a report that recommends new mortality tables for a 
new Group Annuity Reserve Valuation Standard and a new Group Annuity 
Mortality Valuation Standard. In December 1996, the National 
Association of Insurance Commissioners adopted the new tables as models 
for determining reserve liabilities for group annuities. The PBGC is 
considering incorporating these tables into its regulations and making 
other modifications.


Summary of Legal Basis:


The PBGC has the authority to issue rules and regulations necessary to 
carry out the purposes of title IV of ERISA.


Alternatives:


Not yet determined.


Anticipated Cost and Benefits:


Cost estimates are not yet available. However, the PBGC expects that 
this regulation will not have a material effect on costs.


Risks:


Not applicable.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           62 FR 12982                                    03/19/97
ANPRM Comment Period End                                       05/19/97
NPRM                                                           12/00/04
NPRM Comment Period End                                        02/00/05
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None


URL For More Information:
www.pbgc.gov/regs
URL For Public Comments:
www.pbgc.gov/regs
Agency Contact:
James L. Beller
Attorney
Pension Benefit Guaranty Corporation
Office of the General Counsel
1200 K Street NW
Washington, DC 20005-4026
Phone: 202 326-4024
TDD Phone: 800 877-8339
Fax: 202 326-4112
RIN: 1212-AA55
_______________________________________________________________________



PBGC



145.  TRANSPARENCY OF INFORMATION RELATED TO PLAN LIABILITIES
Priority:


Other Significant


Legal Authority:


29 USC 1302(b)(3); 29 USC 1310; 29 USC 1311; 29 USC 1343


CFR Citation:


29 CFR 4010; 29 CFR 4011; 29 CFR 4043


Legal Deadline:


None


Abstract:


The PBGC is considering amending its regulations on required reporting 
or disclosure of certain plan actuarial and employer financial 
information (29 CFR 4010), participant notices (29 CFR 4011), and 
reportable events (29 CFR 4043) to improve disclosure and provide for 
electronic filing of certain information.


Statement of Need:


The PBGC's regulations require disclosure of various information to 
PBGC relating to employer financial condition and plan liabilities (29 
CFR 4010) and events that may threaten future funding of a plan 
(``reportable events'') (29 CFR 4043). PBGC is considering proposing a 
standard format and electronic filing of section 4010 information and 
inclusion of additional detail to assist PBGC in evaluating currently 
reported data. PBGC also is considering proposing to add several new 
reportable events and eliminate some existing waivers from reporting, 
in order to provide PBGC better information about events that may 
threaten plan funding. PBGC regulations also require disclosure of plan 
funding status to participants (``Participant Notice'') by certain 
underfunded plans (29 CFR 4011). PBGC is considering proposing that a

[[Page 72860]]

more accurate measure of plan liabilities be used for purposes of the 
Participant Notice.


Summary of Legal Basis:


The PBGC has the authority to issue rules and regulations necessary to 
carry out the purposes of title IV of ERISA.


Alternatives:


Not yet determined.


Anticipated Cost and Benefits:


Cost estimates are not yet available. However, the PBGC expects that 
this regulation will not have a material effect on costs.


Risks:


Not applicable.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           11/00/04
NPRM Comment Period End                                        12/00/04
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None


URL For More Information:
www.pbgc.gov/regs
URL For Public Comments:
www.pbgc.gov/regs
Agency Contact:
Mr. Harold J. Ashner
Assistant General Counsel
Pension Benefit Guaranty Corporation
Office of the General Counsel
Suite 340
1200 K Street NW
Washington, DC 20005-4026
Phone: 202 326-4024
Fax: 202 326-4112
Email: [email protected]
RIN: 1212-AB01
BILLING CODE 7708-01-S

[[Page 72861]]




SMALL BUSINESS ADMINISTRATION (SBA)



Statement of Regulatory Priorities
Overview
The Small Business Administration's (SBA) mission is to maintain and 
strengthen the Nation's economy by enabling the establishment and 
viability of small businesses and by assisting in economic recovery of 
communities after disasters. In order to accomplish this mission, SBA 
focuses on improving the economic environment for small businesses; 
bridging the competitive opportunity gap facing small business 
entrepreneurs; and providing financial assistance for the restoration 
of homes and businesses affected by disasters.
 SBA is committed to:
 Working with its financial partners to improve small 
            businesses'access to capital through SBA's loan and venture 
            capital programs;
 Providing technical assistance to small businesses throughits 
            resource partners;
 Increasing contracting and business opportunities forsmall 
            businesses;
 Providing affordable, timely, and easily accessible 
            financialassistance to businesses, homeowners, and renters 
            after a disaster;
 Measuring outcomes, such as revenue growth, job 
            creation,business longevity, and recovery rate after a 
            disaster to ensure that SBA's programs and services are 
            delivered efficiently and effectively.
SBA's regulatory actions reflect the goals and objectives of the Agency 
and are designed to provide the small business and residential 
communities with the information and guidance they need to succeed as 
entrepreneurs and restore their homes or other property after a 
disaster. All of SBA's rules concern small businesses and programs that 
promote small businesses. During the coming year, SBA's regulatory 
priorities will focus on strengthening SBA's management of its programs 
and services, increasing subcontracting opportunities for small 
businesses, facilitating their involvement in innovative manufacturing, 
modernizing the Small Business Technology Transfer Program, and 
strengthening the management of the Small Business Lending Company 
Program.
_______________________________________________________________________



SBA

                              -----------

                          PROPOSED RULE STAGE

                              -----------




146. SMALL BUSINESS LENDING COMPANIES REGULATIONS
Priority:


Other Significant


Legal Authority:


15 USC 634(b)(6); 15 USC 636(a); 15 USC 636(b)


CFR Citation:


13 CFR 120.470


Legal Deadline:


None


Abstract:


This rulemaking would amend 13 CFR 120.470 to clarify and strengthen 
the rules regarding Small Business Lending Companies (SBLCs) monitoring 
and oversight for safety and soundness, compliance, and related areas.


Statement of Need:


Section 7(a) of the Small Business Act states that the Small Business 
Administration (SBA) may provide financing to small businesses 
``directly or in cooperation with banks or other financial 
institutions.'' Presently, SBA guarantees loans through approximately 
7,000 lenders. Of these lenders, about 14 are Small Business Lending 
Companies (SBLCs) that are not otherwise regulated by Federal or State 
chartering, licensing, or similar regulatory control. SBA examines or 
audits these SBLCs periodically. Congressional and Administration 
policy to privatize SBA lending and levels in loan volume require that 
SBA increase its SBLC oversight. To that end, SBA will draft 
regulations that strengthen the Agency's management of the SBLC 
Program.


Summary of Legal Basis:


Not required by statute or court order.


Alternatives:


This rulemaking amends and expands SBA's existing regulations on the 
SBLC Program.


Anticipated Cost and Benefits:


This rulemaking is designed to strengthen SBA's regulations regarding 
the SBLC Program. Some additional costs associated with additional 
reporting by the SBLCs to the SBA is anticipated.


Risks:


This regulation poses no risks to the public health and safety or to 
the environment.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           03/00/05
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


 Businesses


Government Levels Affected:


None


Agency Contact:
Janet A. Tasker
Associate Administrator for Lender Oversight
Small Business Administration
409 Third Street SW
Washington, DC 20416
Phone: 202 205-3049
Email: [email protected]
RIN: 3245-AE14
_______________________________________________________________________



SBA



147.  PROPOSED SMALL BUSINESS INNOVATION RESEARCH (SBIR) POLICY 
DIRECTIVE
Priority:


Other Significant. Major status under 5 USC 801 is undetermined.


Unfunded Mandates:


Undetermined


Legal Authority:


15 USC 638(j)(1)


CFR Citation:


None


Legal Deadline:


None


Abstract:


This proposed policy directive incorporates Executive Order 13329 
``Encouraging Innovation in Manufacturing,'' issued February 24, 2004, 
and its requirements into SBA's current SBIR Policy Directive.


Statement of Need:


On February 24, 2004, the President signed Executive Order 13329 
``Encouraging Innovation in Manufacturing.'' The purpose of the 
Executive order is to ensure that Federal Government agencies and

[[Page 72862]]

departments properly and effectively assist the private sector in its 
manufacturing innovation efforts including through the Small Business 
Innovation Research (SBIR) and the Small Business Technology Transfer 
(STTR) programs. Specifically, the Small Business Administration (SBA) 
is required to: 1) Establish, after consultation with the Director of 
the Office and Science and Technology Policy, formats and schedules for 
submission of reports by the heads of departments and agencies; 2) 
issue to departments and agencies guidelines and directives (in 
addition to the formats and schedules) as the Administrator determines 
from time to time are necessary to implement the Executive order, after 
such guidelines and directives are submitted to the President, through 
the Director of the Office of Science and Technology Policy, for 
approval and are approved by the President. In addition, the heads of 
the agencies and departments with one or more SBIR or STTR programs are 
required: 1) To the extent permitted by law and in a manner consistent 
with the mission of that department or agency, to give high priority 
within such programs to manufacturing-related research and development 
to advance innovation including innovation in manufacturing and 2) to 
submit reports annually to the Administrator of the SBA and the 
Director of the Office of Science and Technology Policy concerning the 
efforts of such departments or agencies in implementing this order.


Summary of Legal Basis:


In 1982, Congress enacted the Small Business Innovation Development Act 
of 1982 (SBIDA), Public Law 97-219 (codified at 15 U.S.C. 638), which 
established the Small Business Innovation Research Program (SBIR 
Program). SBIDA requires the SBA to ``issue Policy Directives for the 
general conduct of the SBIR programs within the Federal Government.'' 
(15 U.S.C. 638(j)(1)) In December of 2000, Congress enacted the Small 
Business Innovation Research Program Reauthorization Act of 2000 
(Reauthorization Act), Public Law 106-554. The Reauthorization Act 
extends the SBIR Program through September 30, 2008. SBA published its 
first Policy Directive, Policy Directive No. 65-01, 22 years ago (47 FR 
52966, November 24, 1982). The last SBIR Policy Directive amendments 
were published 2 years ago (67 FR 60072-60098, September 24, 2002).


Alternatives:


There are no practical alternatives that accomplish the objectives 
established by Executive Order 13329. An alternative to amending the 
SBIR and STTR Policy Directives that was considered was to issue a 
Special Policy Information Notice (SPIN) to the participating SBIR and 
STTR agencies and departments. SPINs have been used in the past in 
order to provide clarifying guidance on existing definitions or policy 
matters to the participating SBIR and STTR agencies and departments. As 
Executive Order 13329 was a new Presidential initiative, a SPIN was not 
deemed the appropriate medium for providing guidance to the 
participants. Amending the Policy Directives was identified as the 
method for effective implementation of Executive Order 13329.


Anticipated Cost and Benefits:


This Policy Directive does not impose any new substantive costs to 
small businesses. Further, implementing the Executive Order does not 
impose any substantive cost to the Federal Government. Instead, 
implementing this Executive Order ensures that the Federal agencies and 
departments are assisting the private sector in its manufacturing 
innovation efforts.


Risks:


The amendments to the SBIR and STTR Policy Directives and the 
implementation of Executive Order 13329 pose no risks to the public 
health and safety or to the environment.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           11/00/04
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None


Agency Contact:
Edsel Brown
Assistant Administrator for Technology, Office of Government 
Contracting/Business Development
Small Business Administration
409 Third Street SW
Washington, DC 20416
Phone: 202 205-6450
Email: [email protected]
RIN: 3245-AF21
_______________________________________________________________________



SBA

                              -----------

                            FINAL RULE STAGE

                              -----------




148. SMALL BUSINESS TECHNOLOGY TRANSFER PROGRAM POLICY DIRECTIVE
Priority:


Other Significant


Legal Authority:


15 USC 638; PL 107-50


CFR Citation:


None


Legal Deadline:


Final, Statutory, February 15, 2002, Small Business Technology Transfer 
Program Reauthorization Act of 2001, enacted 10/15/2001, requires 
publication of policy directive modifications.


Abstract:


This policy directive will incorporate recently enacted statutory 
requirements. The purpose of the directive is to provide guidance to 
participating Federal agencies for the general conduct of the Small 
Business Technology Transfer Program.


Statement of Need:


In 1992, Congress enacted the Small Business Technology Transfer Act of 
1992 (STTR Act), Public Law No. 102-564 (codified at 15 U.S.C. 638). 
The STTR Act established the Small Business Technology Transfer Program 
(STTR Program) as a pilot program that required Federal agencies with 
extramural budgets for research or research and development (R/R&D) in 
excess of $1 billion per fiscal year to enter into funding agreements 
with small business concerns (SBCs) that engage in a collaborative 
relationship with a research institution. The purpose of the STTR 
Program is to stimulate a partnership of ideas and technologies between 
innovative SBCs and research institutions. The program assists the 
small business and research communities by developing commercially 
viable technologies. The STTR Program is a phased process, uniform 
throughout the Federal Government, of soliciting proposals and awarding 
funding agreements for R/R&D to meet stated agency needs or missions. 
The STTR Act requires the U.S. Small Business Administration (SBA) to 
``issue a policy directive for the general conduct of the STTR

[[Page 72863]]

Programs within the Federal Government.'' (15 U.S.C. 638(p)(1)) SBA 
published its first STRR Policy Directive in 1993 (58 FR 42607-42620, 
August 10, 1993). This Policy Directive fulfills SBA's statutory 
obligation to provide guidance to the participating Federal agencies 
for the general operation of the STTR Program. Federal agencies 
participating in the STTR Program (STTR agencies) are obligated to 
follow the guidance provided by this Policy Directive. Each agency is 
required to review its rules, policies, and guidance on the STTR 
Program to ensure consistency with this Policy Directive and to make 
any necessary changes in accordance with each agency's normal 
procedures. This is consistent with the statutory authority provided to 
the SBA concerning the STTR Program.


Summary of Legal Basis:


In 1992, Congress enacted the Small Business Technology Transfer Act of 
1992 (STTR Act), Public Law No. 102-564 (codified at 15 U.S.C. 638). 
Congress has since amended the STTR Act, most recently with the 
enactment of the Small Business Technology Transfer Program 
Reauthorization Act of 2001 (Reauthorization Act), Public Law No. 107-
50. The Reauthorization Act extends the STTR Program through September 
30, 2009, and changed its status from a pilot program to a permanent 
one.


Alternatives:


There are no alternatives since it is mandated by law to issue a policy 
directive for the general conduct of the program.


Anticipated Cost and Benefits:


This directive does not impose any new substantive costs to small 
businesses or to the Federal Government. Instead, the directive ensures 
that the Federal agencies and departments are assisting the private 
sector consistent with the directive. The Small Business Technology 
Transfer Program Reauthorization Act of 2001 benefits small businesses 
by requiring participating agencies to increase the amount of their 
extramural budget to be reserved for the STTR Program from 0.15 percent 
to 0.3 percent and permits agencies to increase the dollar value of 
STTR Phase II awards from $500,000 to $750,000.


Risks:


This policy directive poses no risks to the public health and safety or 
to the environment.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Notice of Propos68 FR 35748irective                            06/16/03
Comment Period End                                             07/16/03
Final Action                                                   04/00/05
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


Federal


Agency Contact:
Edsel Brown
Assistant Administrator for Technology, Office of Government 
Contracting/Business Development
Small Business Administration
409 Third Street SW
Washington, DC 20416
Phone: 202 205-6450
Email: [email protected]
RIN: 3245-AE96
_______________________________________________________________________



SBA



149. SMALL BUSINESS GOVERNMENT CONTRACTING PROGRAMS
Priority:


Other Significant. Major status under 5 USC 801 is undetermined.


Legal Authority:


15 USC 634(b)(6); 15 USC 637; 15 USC 644; 31 USC 9701; 31 USC 9702


CFR Citation:


13 CFR 125


Legal Deadline:


None


Abstract:


The U.S. Small Business Administration (SBA) proposes to amend its 
regulation governing small business subcontracting assistance. As 
proposed, the rule would implement additional subcontracting goals 
required by statute, clarify prime contractor responsibilities in 
providing subcontracting opportunities for small businesses, and 
provide additional guidance on evaluating the good faith efforts of 
large businesses to comply with subcontracting plans.


Statement of Need:


On January 31, 2003, SBA published a proposed rule in the Federal 
Register, 67 FR 47244, to solicit comments on its proposal to implement 
several recommendations included in the Office of Management and 
Budget's October 2002 report entitled ``Contract Bundling: A Strategy 
for Increasing Federal Contracting Opportunities for Small Business.'' 
Several of the commenters identified the need for additional guidance 
on evaluating large prime contractor performance and their efforts to 
achieve subcontracting plan goals for small business participation, 
including examples of what constitute ``good-faith'' efforts to comply 
with subcontracting plans. SBA accepted these comments and, in addition 
to the Final Bundling Rule published on October 20, 2003, published a 
proposed rule on that date addressing the major issues in 
subcontracting. In addition to providing guidance on evaluating large 
prime contractor performance and good-faith efforts, the proposed rule 
also authorized the use of goals in subcontracting plans, and/or past 
performance in meeting such goals, as a factor in source selection when 
placing orders against Federal Supply Schedules, Governmentwide 
acquisition contracts, and multi-agency contracts; implemented 
statutory provisions and other administrative procedures relating to 
subcontracting goals and assistance; listed the various categories of 
small businesses that must be afforded maximum practicable 
subcontracting opportunities; and clarified the responsibilities of 
prime contractors and SBA's Commercial Market Representatives (CMRs) 
under the subcontracting assistance program.


Summary of Legal Basis:


The subcontracting assistance program described in this rule is 
authorized by section 8(d) of the Small Business Act. The new 
regulatory provisions incorporated into SBA's regulations at 13 CFR 
125.3 by means of this rule are intended to strengthen SBA's 
implementation of the statute and to respond to the President's agenda 
for small business.


Alternatives:


The alternatives to this rule considered are: (a) To work with the 
Federal Acquisition Regulation (FAR) Council to strengthen the coverage 
in 48 CFR, subpart 19.7, and the related FAR clauses or (b) leave the 
existing coverage in 13 and 48 CFR unchanged. The first of these 
alternatives has been attempted in the past and has proven to be a 
lengthy process, difficult to implement, and the second is unacceptable 
because SBA would have to publish Fact Sheets, Standard Operating 
Procedures, and Best Practice Guides, which do not carry the same 
weight or authority as a regulation and

[[Page 72864]]

would not, therefore, be as effective in strengthening the program.


Anticipated Cost and Benefits:


This rule does not impose any new substantive responsibilities, nor 
does it require any new reporting or recordkeeping requirements on 
small business. Instead, this proposed rule clarifies the existing 
statutory responsibilities under the subcontracting assistance program, 
including the responsibilities of prime contractors to maximize small 
business subcontracting opportunities. It also provides guidance to 
Government officials in monitoring and determining the achievements of 
subcontracting goals. In fiscal year 2002, the most recent year for 
which the Government has reliable subcontracting data, small business 
received approximately $34.4 billion in subcontract awards representing 
more than 35 percent of all subcontract dollars. As a result of this 
regulation, subcontracting opportunities in the year(s) following 
publication of the Final Rule.


Risks:


This regulation poses no risks to the public health and safety or to 
the environment.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            68 FR 60015                                    10/20/03
NPRM Comment Period End                                        12/19/03
Final Action                                                   12/00/04
Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Dean Robert Koppel
Assistant Administrator, Policy and Research
Small Business Administration
409 Third Street SW
Washington, DC 20416
Phone: 202 205-7322
Email: [email protected]
RIN: 3245-AF12
BILLING CODE 8025-01-S

[[Page 72865]]




SOCIAL SECURITY ADMINISTRATION (SSA)



Statement of Regulatory Priorities
The Social Security Administration (SSA) administers the retirement, 
survivors, and disability insurance programs under title II of the 
Social Security Act (the Act) and the Supplemental Security Income 
(SSI) program under title XVI of the Act. As directed by Congress, we 
also assist in administering portions of the Medicare program. Our 
regulations codify the requirements for eligibility and entitlement to 
benefits under the programs that we administer. Generally, SSA's 
regulations do not impose burdens on the private sector or on State or 
local governments.
Our 19 entries for the Regulatory Plan represent areas of major 
importance to the administration of the retirement, survivors, 
disability, SSI, and Medicare benefit programs. Each individual 
initiative is described more fully after this Statement of Regulatory 
Priorities. Several of these regulatory priorities reflect the 
provisions of two major laws that were recently enacted--the Medicare 
Prescription Drug, Improvement and Modernization Act of 2003 (Pub. L. 
108-173) and the Social Security Protection Act of 2004 (Pub. L. 108-
203).
Serve the Public
Providing the best service possible to the public remains a principal 
objective of SSA. To that end, we have included in the Plan three 
initiatives to improve public service.
We plan to revise our regulations to permit an Administrative Law Judge 
to incorporate into the written decision, when wholly favorable, the 
findings and reasons stated orally at a hearing, if they remain 
applicable. We believe this revision may reduce the time needed to 
issue wholly favorable decisions after a hearing.
We are including a proposed rule that would describe additional 
safeguards against inappropriate disclosure of personal information and 
set out special procedures concerning access to medical records.
Furthermore, we are including another proposed rule that would, among 
other changes, revise our privacy and disclosure rules to further 
preserve the anonymity and protect the physical well being of employees 
who are threatened by others.
Improve the Disability Process
As the continued improvement of the disability program is an area of 
vital interest to SSA, we have included in the Plan seven initiatives 
that address disability.
Two initiatives would update the medical listings used to determine 
disability: a final rule on neoplastic diseases and a proposed rule on 
immune system disorders. The revisions will ensure that the listings 
reflect advances in medical knowledge, treatment, and methods of 
evaluating these impairments.
A final rule will provide for continued benefit payments to certain 
individuals who recover medically while participating in certain 
vocational rehabilitation programs.
A proposed rule would revise several areas of our regulations on the 
Ticket to Work program to improve the support of disabled individuals 
who want and need assistance to return to the workforce.
Another proposed rule would establish time limits and other criteria 
for individuals receiving disability benefits who wish to initiate 
plans to achieve self-support.
A proposed rule would explain the standards we use to evaluate the work 
activity of an individual receiving disability benefits, and when we 
will conduct a continuing disability review.
Another proposed rule would, among other changes, require us to issue a 
receipt when an individual receiving disability benefits reports a 
change in work activity or earnings. This rule would also include home 
schooling as a form of regular school attendance for purposes of the 
Student Earned Income Exclusion. This rule reflects provisions of the 
Social Security Protection Act of 2004.
Improve Stewardship
SSA bears a responsibility to ensure we are effective stewards of the 
public trust placed in us. We are including in the Plan several 
regulatory initiatives designed to strengthen our stewardship and 
program integrity activities; some also reflect the goal to improve 
financial performance contained in the President's Management Agenda.
For beneficiaries who are not able to manage their own benefits due to 
legal incompetence or medical infirmity, we must assure that benefits 
paid to representatives on their behalf are used properly. We are 
developing proposed rules that reflect provisions of the Social 
Security Protection Act of 2004 intended to strengthen our oversight of 
the representative payee program.
The Debt Collection Improvement Act of 1996, as amended by the Foster 
Care Independence Act of 1999, provided SSA with new tools for our 
efforts in collecting debts, including the use of administrative wage 
garnishment. We are developing a proposed rule on Federal salary offset 
that will enable us to collect qualifying, delinquent title II and XVI 
debts owed by former beneficiaries who are currently employed by the 
Federal government.
One final rule will expand our ability to recover overpayments made in 
one of our programs from benefits payable under other programs we 
administer. This final rule reflects a provision of the Social Security 
Protection Act of 2004.
A proposed rule would prohibit title II benefits to persons fleeing 
prosecution, custody, or confinement after conviction, and to persons 
violating probation or parole. This proposed rule reflects a provision 
of the Social Security Protection Act of 2004.
Another proposed rule would enhance our program integrity efforts by 
expanding our civil monetary penalties program. Included, among other 
activities, would be solicitations or mailings by outside individuals 
or entities that mislead the public into believing that SSA either 
approves, endorses, or authorizes the solicitations or mailings.
Simplify the SSI Program
SSA is including two rules that would simplify our SSI regulations.
One final rule will modify three areas concerning what we consider as 
income or resources available to an applicant or recipient. We will no 
longer consider gifts of clothing as income when we decide whether a 
person can receive SSI benefits or when we compute the amount of 
benefits. We will also exclude, from our determination of resources, 
one automobile if it is used for transportation, without consideration 
of its value. Finally, we will no longer count household goods and 
personal effects as resources when we decide whether a person can 
receive SSI benefits.
A proposed rule would change our rules for deeming of income and 
resources from a stepparent to an eligible child when the child resides 
with a stepparent but not the natural or adoptive parent. We believe 
this change will simplify the rules concerning deeming under these 
circumstances.

[[Page 72866]]

Implement Medicare Legislation
SSA does not have overall responsibility for the Medicare program under 
title XVIII of the Social Security Act. However, the Medicare 
Prescription Drug, Improvement and Modernization Act of 2003 directs 
SSA to assist in administering portions of the Medicare program. We are 
including in the Plan two proposed rules that would implement the 
legislation.
First, we propose to include rules concerning Medicare Prescription 
Drug premium and cost-sharing subsidies (Medicare part D).
Second, we propose rules on reduction of premium subsidies for the 
Supplementary Medical Insurance Benefit program (Medicare part B).
_______________________________________________________________________



SSA

                              -----------

                          PROPOSED RULE STAGE

                              -----------




150. PRIVACY AND DISCLOSURE OF OFFICIAL RECORDS AND INFORMATION (711P)
Priority:


Other Significant


Legal Authority:


5 USC 552; 5 USC 552a; 42 USC 1306(a); 42 USC 902(a)(5)


CFR Citation:


20 CFR 401.30; 20 CFR 401.45; 20 CFR 401.55; 20 CFR 401.150; 20 CFR 
401.180


Legal Deadline:


None


Abstract:


We propose to revise our privacy and disclosure rules to:


1. More fully describe the role and function of the Privacy Officer;


2. Describe safeguards against inappropriate disclosure of personal 
information when individuals request information about themselves by 
electronic means (e.g., through the Internet);


3. Conform to special procedures on an individual's access to medical 
records; and


4. Add a new section to grant direct access to a minor's medical 
records by the minor's parent or legal guardian acting on the minor's 
behalf.


Statement of Need:


These revised regulations are necessary to:


1. Provide the expanded regulatory support for the existing 
responsibilities and functions of the Privacy Officer as required by 
the Privacy Act and related Office of Management and Budget (OMB) 
guidelines;


2. Articulate the safeguards that ensure the appropriate procedures for 
access to and disclosure of personally identifiable information in the 
electronic environment;


3. Conform the regulations to our practice and systems of records, 
which set out special procedures under which individuals whose medical 
records may potentially present an adverse effect may have access to 
this information; and


4. Conform to the special procedures in our systems of records for 
access to medical records.


Summary of Legal Basis:


Revisions are needed to incorporate into the regulations special 
procedures for providing individuals access to their medical records to 
ensure the ultimate disclosure of the records to the requesting 
individual, as set out in our systems of records.


Alternatives:


None.


Anticipated Cost and Benefits:


1. Revised role of Privacy Officer:


 Cost - To be determined.


 Benefit - Increased public awareness of the privacy officer's role and 
responsibility in protecting the privacy and disclosure of the 
information SSA collects and maintains; general oversight to the Agency 
on privacy and disclosure activities.


2. Description of safeguards against inappropriate disclosure of 
personal information by electronic means:


 Cost - To be determined.


 Benefit - Increase public awareness of the safeguards employed by SSA 
to maintain the security, confidentiality, and integrity of the 
information we collect and maintain.


3. Conform to special procedures on an individual's access to medical 
records; and


4. Add a new section to grant direct access to a minor's medical 
records by the minor's parent or legal guardian acting on the minor's 
behalf:


 Cost - To be determined.


 Benefit - Regulatory guidelines will facilitate access for individuals 
whose medical records may have adverse effects.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           03/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Chris W. Johnson
Social Insurance Specialist
Social Security Administration
Office of the General Counsel
Office of Public Disclosure
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-8563

Suzanne DiMarino
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235
Phone: 410 965-1769
RIN: 0960-AE88
_______________________________________________________________________



SSA



151. FEDERAL SALARY OFFSET (WITHHOLDING A PORTION OF A FEDERAL 
EMPLOYEE'S SALARY TO COLLECT A DELINQUENT DEBT OWED TO THE SOCIAL 
SECURITY ADMINISTRATION) (721P)
Priority:


Other Significant


Legal Authority:


42 USC 404; 42 USC 405; 42 USC 902; 42 USC 1383; 5 USC 5514


CFR Citation:


20 CFR 422


Legal Deadline:


None


Abstract:


This initiative would enable the Social Security Administration (SSA) 
to

[[Page 72867]]

collect from Federal salaries qualifying, delinquent title II and title 
XVI overpayment debts, and administrative debts owed by individuals who 
are currently Federal employees. The debt collection would be 
accomplished by the partial reduction of the employee's disposable 
salary.


Statement of Need:


This regulation is required by 5 U.S.C. 5514(b) and by regulations of 
the Department of the Treasury (Treasury) and the Office of Personnel 
Management (OPM) in order for SSA to participate in the Federal Salary 
Offset program. Treasury's regulation is 31 CFR 285.7; OPM's regulation 
is 5 CFR 550.1104.


Summary of Legal Basis:


SSA's use of the Federal Salary Offset program is authorized by 42 
U.S.C. 404(f), 42 U.S.C. 1383(b) and 5 U.S.C. 5514.


Alternatives:


None. SSA must have regulations, approved by OPM, in order to use 
Federal salary offset to collect debts owed by Federal employees. See 5 
U.S.C. 5514(b), 5 CFR 550.1104, and 31 CFR 285.7.


Anticipated Cost and Benefits:


Undetermined at this time.


Risks:


At this time we have not identified any risks associated with the 
proposal.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           03/00/05
Final Action                                                   09/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal


Agency Contact:
Edward Johns
Financial Management Analyst
Social Security Administration
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-0392

Robert J. Augustine
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-0020
RIN: 0960-AE89
_______________________________________________________________________



SSA



152. EXEMPTION OF WORK ACTIVITY AS A BASIS FOR A CONTINUING DISABILITY 
REVIEW (TICKET TO WORK AND WORK INCENTIVES IMPROVEMENT ACT OF 1999) 
(725P)
Priority:


Other Significant


Legal Authority:


42 USC 421(m)


CFR Citation:


20 CFR 404.903; 20 CFR 404.1574; 20 CFR 404.1575; 20 CFR 404.1590; 20 
CFR 404.1592a; 20 CFR 404.1594; 20 CFR 416.974; 20 CFR 416.990; 20 CFR 
416.994; 20 CFR 416.1403


Legal Deadline:


None


Abstract:


We are proposing to amend our regulations to explain how we will 
implement section 221(m) of the Social Security Act (the Act). We are 
also proposing to amend our regulation to eliminate the use of the 
secondary substantial gainful activity amount for evaluating work done 
by an employee prior to January 2001. Section 221(m) affects our rules 
for when we will conduct a continuing disability review if a 
beneficiary works and receives benefits under title II of the Act based 
on disability. (We interpret this section to include beneficiaries who 
receive both title II disability benefits and Supplemental Security 
Income (SSI) payments based on disability.) It also affects the way we 
evaluate work activity when deciding if a beneficiary has engaged in 
substantial gainful activity, and affects the standards we use when we 
determine whether disability continues or ends.


Statement of Need:


This regulation is necessary to clarify how SSA will implement section 
221(m) of the Social Security Act, which prohibits starting continuing 
disability reviews for certain beneficiaries based on work activity, 
and limits the use of the work activity of certain beneficiaries as 
evidence that the individual is no longer disabled.


Summary of Legal Basis:


This regulation implements section 221(m) of the Social Security Act, 
which was added by section 111 of Public Law 106-170.


Alternatives:


None.


Anticipated Cost and Benefits:


Over a five year period, this regulation will result in a net 
administrative cost of about $10 million and an SSA workyear savings of 
420 workyears. The estimates for costs are $165 million in the first 
five years.


Risks:


At this time we have not identified any risks associated with this 
proposal.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           01/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Kristine Erwin-Tribbitt
Social Insurance Specialist
Social Security Administration
Office of Program Development and Research
6401 Security Boulevard
Baltimore, MD 21235
Phone: 410 965-3353

Suzanne DiMarino
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235
Phone: 410 965-1769
RIN: 0960-AE93

[[Page 72868]]

_______________________________________________________________________



SSA



153. REVISED MEDICAL CRITERIA FOR EVALUATING IMMUNE SYSTEM DISORDERS 
(804P)
Priority:


Other Significant


Legal Authority:


42 USC 405; 42 USC 902(a)(5); 42 USC 1383


CFR Citation:


20 CFR 404.1500, app 1


Legal Deadline:


None


Abstract:


We propose to update and revise the rules that we use to evaluate 
immune system disorders of adults and children who apply for, or 
receive, disability benefits under title II and Supplemental Security 
Income (SSI) payments based on disability under title XVI of the Social 
Security Act (the Act). The rules we plan on revising are sections 
14.00 and 114.00 in the Listing of Impairments in appendix 1 to subpart 
P of part 404 of our regulations (the listings). These listings include 
such disorders as HIV infection, other Immunoglobulin deficiency 
syndromes or deficiencies of cell-mediated immunity, System Lupus 
Erythematosus, Scleroderma, Polymyositis, Inflammatory Arthritis, and 
other connective tissue disorders.


Statement of Need:


These regulations are necessary to update the listings for evaluating 
immune system disorders to reflect advances in medical knowledge, 
treatment, and methods of evaluating these diseases. They ensure the 
determinations of disability have a sound medical basis, that claimants 
receive equal treatment through the use of specific criteria, and that 
individuals who are disabled can be readily identified and awarded 
benefits if all other factors of entitlement or eligibility are met.


Summary of Legal Basis:


Administrative-not required by statute or court order


Alternatives:


We considered not revising the listings or making only minor technical 
changes. However, we believe that proposing these revisions is 
preferable because of the medical advances that have been made in 
treating and evaluating these types of diseases. The current listings 
are now over 11 years old. Medical advances in disability evaluation 
and treatment and our program experience make clear that the current 
listings do not reflect state-of-art medical knowledge and technology.


Anticipated Cost and Benefits:


We anticipate that if finalized, these proposed rules would result in 
negligible program and administrative costs.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           68 FR 24896                                    05/09/03
ANPRM Comment Period End                                       07/08/03
NPRM                                                           01/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Paul J. Scott
Social Insurance Specialist
Social Security Administration
Office of Disability Programs
Office of Disability Programs
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 966-1192

Suzanne DiMarino
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235
Phone: 410 965-1769
RIN: 0960-AF33
_______________________________________________________________________



SSA



154. AMENDMENTS TO THE TICKET TO WORK AND SELF-SUFFICIENCY PROGRAM 
(967P)
Priority:


Economically Significant. Major status under 5 USC 801 is undetermined.


Legal Authority:


42 USC 902(a)(5); 42 USC 1320b-19; PL 106-170, sec 101


CFR Citation:


20 CFR 411.115; 20 CFR 411.125 to 411.140; 20 CFR 411.150 to 411.155; 
20 CFR 411.171; 20 CFR 411.350 to 411.375; 20 CFR 411.385 to 411.395; 
20 CFR 411.500 to 411.510; 20 CFR 411.525 to 411.565; 20 CFR 411.575 to 
411.585


Legal Deadline:


None


Abstract:


These proposed rules are intended to amend the final rules implementing 
the Ticket to Work and Self-Sufficiency Program under section 1148 of 
the Social Security Act: to expand beneficiary eligibility to receive 
tickets under this program; to clarify the rules for assignment of a 
beneficiaries' ticket to a State vocational rehabilitation (VR) agency; 
to revise the rules for payment when a beneficiary receives services 
from both a State VR agency and an employment network (EN); and, 
consistent with the Commissioner's authority in section 1148(h) of the 
Act, to revise the rules for milestone and outcome payments to ENs, in 
order to increase the incentives for providers of employment and other 
support services to participate in this program.


Statement of Need:


This proposed regulatory action is necessary to respond to our 
experience and recommendations we have received since we began 
implementation of the Ticket to Work and Self-Sufficiency Program in 
February 2002, in order to increase the incentives for providers of 
employment services, vocational rehabilitation services, and other 
support services to participate in this program, and to expand the 
options available to beneficiaries with disabilities to obtain services 
to assist them to go to work and attain self-sufficiency.


Summary of Legal Basis:


None.


Alternatives:


We considered not revising the current regulations implementing the 
Ticket to Work program. However, we believe that these revisions to 
eligibility to receive a ticket, to clarify the rules for assignment of 
a ticket to a State VR agency, and to amend the rules for paying ENs 
are necessary to increase participation in the Ticket to Work program 
by providers of services and by beneficiaries with disabilities, in 
order to ensure that these beneficiaries can seek the services 
necessary to obtain and retain employment and reduce their dependency 
on cash benefit programs.

[[Page 72869]]

Anticipated Cost and Benefits:


We anticipated initial costs to increase due to up-front payments to 
ENs, and potential savings in later years as ENs are encouraged to 
serve additional beneficiaries and assist them to achieve self-
sufficiency and reduce their dependency on cash benefit programs, 
including the Supplemental Security Income and Social Security 
Disability Insurance programs.


Risks:


At this time, we have not identified any risks associated with this 
proposal.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           01/00/05
Final Action                                                   05/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


State


Agency Contact:
Barbara Leary
Social Insurance Specialist
Social Security Administration
Office of Employment Support Programs
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-7764

Suzanne DiMarino
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235
Phone: 410 965-1769
RIN: 0960-AF89
_______________________________________________________________________



SSA



155. ELIMINATION OF PARENT-TO-CHILD DEEMING FOR INDIVIDUALS WHO NO 
LONGER MEET THE DEFINITION OF SPOUSE OF THE NATURAL OR ADOPTIVE PARENT 
(793P)
Priority:


Other Significant. Major status under 5 USC 801 is undetermined.


Legal Authority:


Sec 1614(f)(2) of the Social Security Act


CFR Citation:


20 CFR 416.1160; 20 CFR 416.1165; 20 CFR 416.1202; 20 CFR 416.1851


Legal Deadline:


None


Abstract:


We propose to change the Supplemental Security Income (SSI) parent-to-
child deeming rules to no longer consider the income and resources of a 
stepparent when an eligible child resides in the household with a 
stepparent, but not his or her natural or adoptive parent. We will 
clarify that a stepparent no longer meets the definition of a 
``parent'' when his or her spouse dies or leaves the household. Thus, 
an eligible child is not subject to deeming from a stepparent unless 
the child lives with both his or her natural or adoptive parent and the 
stepparent. We also propose changing the age at which an individual is 
no longer considered an ineligible child for purposes of deeming from 
21 to 22. We believe this change will simplify our rules for both the 
public and our public contact employees.


Statement of Need:


The U.S. Court of Appeals, Second Circuit, ruled on a case involving a 
natural parent who abandoned the family home leaving her spouse with 
sole physical custody of an eligible child. Social Security 
Acquiescence Ruling 99-1(2) currently applies the Court's decision to 
the States of Connecticut, Vermont, and New York. The proposed rules 
will set uniform national policy with respect to this issue. Further, 
changing the definition of ``ineligible child'' for purposes of deeming 
will make uniform all regulatory definitions of ``child'' for SSI 
purposes. This will simplify our rules, making them less cumbersome to 
administer and easier for the public to understand and follow.


Summary of Legal Basis:


None.


Alternatives:


None.


Anticipated Cost and Benefits:


We estimate that the program costs and administrative costs for these 
regulatory changes would be negligible.


Risks:


These proposed rules will ensure our parent-to-child deeming rules are 
consistent with respect to our current regulatory definition of 
``parent'' and ``child.'' Policy will uniformly be set nationwide and 
will make our rules less difficult for the public to understand.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/04
Final Action                                                   09/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Karen E. Kerwath
Social Insurance Specialist
Social Security Administration
Office of Income Security Programs
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-9835

Richard M. Bresnick
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235
Phone: 410 965-1758
Related RIN: Related to 0960-AF24
RIN: 0960-AF96
_______________________________________________________________________



SSA



156. RULES FOR HELPING BLIND AND DISABLED INDIVIDUALS ACHIEVE SELF-
SUPPORT (506P)
Priority:


Other Significant


Legal Authority:


42 USC 902(a)(5); 42 USC 1381a; 42 USC 1382; 42 USC 1382a; 42 USC 
1382b; 42 USC 1382c(f); 42 USC 1382j; 42 USC 1383; 42 USC 1382 note


CFR Citation:


20 CFR 416.1180; 20 CFR 416.1181; 20 CFR 416.1226


Legal Deadline:


None


Abstract:


We are proposing to amend our regulations to explain how we implement 
section 203 of the Social Security Independence and Program 
Improvements Act of 1994 (Pub. L. 103-296). Section 203 of this law 
amended section 1633 of the Social Security Act

[[Page 72870]]

to require us to establish by regulations criteria for time limits and 
other criteria related to plans to achieve self-support (PASS). The law 
requires that the time limits take into account the length of time that 
a person needs to achieve his or her occupational goal, within a 
reasonable period, and other factors as determined by the Commissioner 
to be appropriate.


Statement of Need:


This regulation is necessary to implement the changes in section 1633 
of the Social Security Act regarding time limits and other criteria 
deemed necessary by the Commissioner.


Summary of Legal Basis:


42 U.S.C. 1383b authorizes the Commissioner to promulgate regulations 
for the purpose of establishing criteria for time-limits and other 
criteria deemed necessary related to the PASS program.


Alternatives:


None.


Anticipated Cost and Benefits:


We estimate that the administrative impact would be negligible.


Risks:


At this time we have not identified any risks associated with this 
proposal.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           06/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Mary Hoover
Social Insurance Specialist
Social Security Administration
Office of Program Development and Research
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-5651

Fran O. Thomas
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 966-9822
Fax: 410 966-2830
Email: [email protected]
Related RIN: Previously reported as 0960-AE17
RIN: 0960-AG00
_______________________________________________________________________



SSA



157. MEDICARE PRESCRIPTION DRUG PREMIUM AND COST-SHARING (1024P)
Priority:


Other Significant. Major status under 5 USC 801 is undetermined.


Legal Authority:


PL 108-173; 42 USC 405


CFR Citation:


None


Legal Deadline:


None


Abstract:


We propose to add to our regulations, a new part 418 that would contain 
our rules applicable to claims for premium and cost-sharing subsidies 
under Medicare and to include a new subpart D, Medicare part D 
Subsidies. These rules would describe: how we determine whether an 
individual is eligible for premium and cost-sharing subsidies; how we 
determine subsidy eligibility; how we redetermine subsidy eligibility; 
the subsidy application process; when eligibility for premium and cost-
sharing subsidies terminates; reporting requirements; and how 
individuals may appeal a determination we make under the part D subsidy 
Program.


Statement of Need:


SSA is responsible for determining premium and cost-sharing subsidy 
eligibility for the new Medicare Prescription Drug Benefit. The 
provision will be implemented in January 2007.


Summary of Legal Basis:


Section 1860D-14 of the Social Security Act provides for premium and 
cost-sharing subsidies for certain low-income individuals, and directs 
the Social Security Administration to develop a simplified application 
process.


Alternatives:


None.


Anticipated Cost and Benefits:


The Centers for Medicare and Medicaid Services (CMS) has developed 
detailed cost estimates for implementation of the Prescription Drug 
Benefits program. These costs are explained in a CMS Notice of Proposed 
Rulemaking (CMS-4068P; 69 FR 46632; 08/03/2004). SSA administrative 
costs are not yet known. The benefit of developing agency regulations 
for a simplified subsidy application are that many beneficiaries with 
incomes below 150 percent of the poverty level, and limited resources, 
will be able to get help with paying premiums and cost-sharing for 
Medicare part D coverage.


Risks:


There are inherent risks in any form of public benefit which requires 
means-testing. The risks for the prescription drug benefit premium and 
cost-sharing subsidy program are increased by the requirement that SSA 
use a simplified application process.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/04
Final Action                                                   09/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Undetermined

[[Page 72871]]

Agency Contact:
Craig Street
Social Insurance Specialist
Social Security Administration
Office of Income Security Programs
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-9793

Lois A. Berg
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-1713
RIN: 0960-AG03
_______________________________________________________________________



SSA



158.  CIVIL MONETARY PENALTIES, ASSESSMENTS, AND RECOMMENDED 
EXCLUSIONS (2362P)
Priority:


Other Significant


Legal Authority:


42 USC 902(a)(5); 42 USC 1320a-8; 42 USC 1320b-10


CFR Citation:


20 CFR 498.100 TO 498.104; 20 CFR 498.106; 20 CFR 498.109; 20 CFR 
498.114; 20 CFR 498.128


Legal Deadline:


None


Abstract:


The mission of the Social Security Administration, Office of the 
Inspector General (SSA/OIG), is to protect SSA programs and operations 
from fraud, waste, and abuse. Critical to this mission is ensuring that 
SSA provide Social Security benefits in the correct amount to those who 
meet the applicable requirements. Therefore, anyone who makes a false 
statement of material fact to obtain or retain benefits to which they 
are not entitled adversely impacts both SSA programs and the mission of 
the OIG to protect those programs. Also critical to SSA's operations is 
the relationship of trust that it has established with citizens of this 
country; particularly the elderly and/or disabled individuals for who 
Social Security is vital to their continued existence. Therefore, it is 
imperative that outside individuals/entities not abuse or damage that 
trust by using certain words associated with SSA in any solicitation/
mailing in such a way to mislead the public into believing that SSA 
either approves, endorses, or authorizes such solicitation/mailing. The 
Social Security Act provides authority to impose civil monetary 
penalties and assessments against anyone who knowingly submits a false 
statement of material fact to SSA to obtain or retain benefits to which 
they are not entitled and civil monetary penalties against any 
individual or organization who misleads the public into believing that 
they are affiliated with or approved or endorsed by SSA by utilizing 
SSA's symbols and program words. Congress determined that expansion of 
the civil monetary penalty authority was needed to assure the integrity 
of SSA's programs and operations. These proposed regulations are 
required to enhance our program integrity efforts.


Statement of Need:


These proposed regulations, would reflect certain provisions of Public 
Law 106-169 and 108-203, modify the existing procedures for the 
imposition of a civil monetary penalty and assessment, as applicable, 
under sections 1129 of the Social Security Act (42 U.S.C. 1320a-8) by: 
(1) amending the regulations to reflect the expanded authority under 
section 1129 to impose a civil monetary penalty and assessment for 
fraud involved in the receipt of benefits under title VIII of the 
Social Security Act; and (2) adding as new categories for civil 
monetary penalty and assessment under section 1129 (i) representative 
payees with respect to wrongful conversions, and (ii) individuals who 
withhold the disclosure of material facts to the SSA.


These proposed regulations would also reflect certain provisions of 
Public Law 108-203 and modify the existing procedures for the 
imposition of a civil monetary penalty under section 1140 of the Social 
Security Act (42 U.S.C. 1320b-10) by: (1) requiring an advertiser or 
direct marketer who offers to assist an individual in obtaining 
products or services for a fee, that SSA otherwise provides free of 
charge, to include a written notice on the solicitation/mailing that 
the product or service is available from SSA free of charge; and (2) 
expanding the list of terms in section 1140 that encompass the scope of 
words or phrases that the statute prohibits from being used in a 
misleading manner.


Summary of Legal Basis:


These proposed regulations would implement section 251(b)(6) of Public 
Law 106-169 and sections 111, 201, 204 and 207 of Public Law 108-203.


Alternatives:


None.


Anticipated Cost and Benefits:


Cost--None.


Benefits--These regulations are required to enhance our program 
integrity efforts.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           01/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Kathy Buller
Chief Counsel to the Inspector General
Social Security Administration
Office of the Inspector General
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-2827

Fran O. Thomas
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 966-9822
Fax: 410 966-2830
Email: [email protected]
RIN: 0960-AG08
_______________________________________________________________________



SSA



159.  REPRESENTATIVE PAYMENT; ADDITIONAL PROTECTIONS FOR 
PERSONS WITH REPRESENTATIVE PAYEES (2422P)
Priority:


Other Significant


Legal Authority:


42 USC 405(j); 42 USC 1007; 42 USC 1383(a)(2)


CFR Citation:


20 CFR 404.2022; 20 CFR 404.2035; 20 CFR 404.2040(a); 20 CFR 404.2045; 
20 CFR 404.2065; 20 CFR 408.622; 20 CFR

[[Page 72872]]

408.635; 20 CFR 408.645; 20 CFR 408.665; 20 CFR 416.622; 20 CFR 
416.635; 20 CFR 416.640(a); 20 CFR 416.645


Legal Deadline:


None


Abstract:


Effective stewardship of SSA programs requires mechanisms to assure 
that benefits are used to meet the needs of beneficiaries judged 
incapable of managing or directing someone else to manage their 
benefits. Congress determined that improvements to the representative 
payment procedures were needed to assure program integrity. These 
proposed regulations are required to further our program integrity 
efforts.


Statement of Need:


These proposed regulations, which reflect certain provisions of Public 
Law 108-203, would modify existing representative payee procedures by: 
(1) expanding the scope of disqualification to prohibit an individual 
from serving as representative payee if he or she is convicted of 
offenses resulting in imprisonment for more than one year or is fleeing 
to avoid prosecution, custody, or confinement after conviction; (2) 
requiring annual certifications from nongovernmental fee for service 
organizational payees that they are licensed and bonded; (3) requiring 
a fee for service representative payee to forfeit their fee for the 
months during which funds were misused; (4) requiring a representative 
payee to receive benefits in person at a local social security field 
office if they fail to provide an annual accounting of benefits; and 
(5) explaining financial requirements for representative payees.


Summary of Legal Basis:


These proposed regulations implement sections 102, 103, 104 and 106 of 
Public Law 108-203.


Alternatives:


None.


Anticipated Cost and Benefits:


Any costs associated with these regulations are reflected in the 
President's budget as part of legislative implementation. They are 
required to further our program integrity efforts.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           11/00/04
Final Action                                                   08/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Organizations


Government Levels Affected:


None


Agency Contact:
Betsy Byrd
Social Insurance Specialist
Social Security Administration
Office of Income Security Programs
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-7981

Robert J. Augustine
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-0020
RIN: 0960-AG09
_______________________________________________________________________



SSA



160.  ISSUANCE OF WORK REPORT RECEIPTS, PAYMENT OF TRIAL WORK 
PERIOD MONTHS AFTER A FRAUD CONVICTION AND CHANGES TO THE STUDENT 
EARNED INCOME EXCLUSION (2502P)
Priority:


Other Significant


Legal Authority:


42 USC 402; 42 USC 403; 42 USC 404(a); 42 USC 404(e); 42 USC 405(a) to 
405(d); 42 USC 405(h); 42 USC 405 note; 42 USC 416(1); 42 USC 421(a); 
42 USC 421(i); 42 USC 421 note ; 42 USC 422(c); 42 USC 423(e); 42 USC 
425; 42 USC 902(a); 42 USC 902(5); 42 USC 902 note; 42 USC 1320 a-8a; 
42 USC 1320 b-17; 42 USC 1381; 42 USC 1382; 42 USC 1382 note; 42 USC 
1383


CFR Citation:


20 CFR 404.401a; 20 CFR 404.471; 20 CFR 404.903; 20 CFR 404.1588; 20 
CFR 404.1592; 20 CFR 416.708(c); 20 CFR 416.1112(c)(3); 20 CFR 
416.1403; 20 CFR 416.1861


Legal Deadline:


None


Abstract:


We are proposing to amend our rules to carry out sections 202, 208, and 
432 of the Social Security Protection Act (SSPA) of 2004. The SSPA 
provides safeguards to Social Security and Supplemental Security Income 
(SSI) beneficiaries who have representative payees and enhances program 
protections. Section 202 of the SSPA requires us to issue a receipt to 
you each time you report a change in your work activity or give us 
documentation of a change in your earnings if you receive benefits 
based on disability under titles II or XVI of the Act. In section 208, 
benefits for certain months during the trial work period becomes 
nonpayable if you are convicted by a Federal court of fraudulently 
concealing work activity. Section 432 changes the way we decide if you 
are eligible for the Student Earned Income Exclusion. We also propose 
to change the SSI student policy to include home schooling as a form of 
regular school attendance.


Statement of Need:


This regulation is necessary to implement the program improvements 
established in the SSPA. The regulation will improve our service to 
individual beneficiaries who attempt to work and improve our ability to 
protect the programs from certain types of fraud.


Summary of Legal Basis:


This regulation implements sections 202, 208, and 432 of Public Law 
108-203.


Alternatives:


None.


Anticipated Cost and Benefits:


Improved service to beneficiaries and improved protections from fraud 
for the programs.


Risks:


At this time we have not identified any risks to this proposal.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           03/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None

[[Page 72873]]

Agency Contact:
Cindy Duzan
Social Insurance Specialist
Social Security Administration
Office of Program Development and Research
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-4203

Suzanne DiMarino
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235
Phone: 410 965-1769
RIN: 0960-AG10
_______________________________________________________________________



SSA



161.  INCOME RELATED MEDICARE PART B PREMIUM SUBSIDY REDUCTION 
(2101P)
Priority:


Other Significant. Major status under 5 USC 801 is undetermined.


Legal Authority:


42 USC 405; PL 108-173


CFR Citation:


20 CFR 418 (New)


Legal Deadline:


None


Abstract:


We propose to add to our regulations a new part 418 that would include 
our rules applicable to reduction of premium subsidies for high income 
beneficiaries. Section 811 of the Medicare Prescription Drug, 
Improvement and Modernization Act of 2003 amends section 1839 of the 
Act. Starting in 2007, the new subsection 1839(i) requires that 
Medicare part B enrollees with high income receive a reduced part B 
premium subsidy. The statute establishes four income range ``notches'' 
above a threshold, and prescribes a percentage adjustment of premiums 
for each notch. As income increases, the premium subsidy decreases; in 
effect, the higher the income, the higher the part B premium. All 
beneficiaries will continue to receive some part B premium subsidy. The 
income threshold in 2007 is $80,000 ($160,000 for an individual who 
files a joint income tax return). The premium adjustments will be 
phased in over a five year period between 2007 and 2011. After 2007, 
the threshold amount and all of the notch amounts will be annually 
adjusted for inflation.


Statement of Need:


Regulations required by statute.


Summary of Legal Basis:


Section 1839(i) of the Social Security Act.


Alternatives:


None. The Social Security Act directs the Commissioner to establish 
regulations to implement this provision. The statute requires the 
Commissioner to establish regulations regarding temporary use of tax 
year data from a year other than the year ordinarily used to determine 
premium adjustments, establishment of premiums for Medicare part B 
enrollees who do not file income taxes, and specification of ``life-
changing events'' that meet the standard for use of more recent tax 
year data.


Anticipated Cost and Benefits:


The Income Related Medicare part B premium adjustment was established 
to produce Federal savings in the Medicare program. The Congressional 
Budget Office estimates that this provision will produce $13.3 billion 
in savings between 2007 and 2013. SSA will have administrative costs in 
implementing the provision, which have been considered in the savings 
estimates.


Risks:


None identified.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           07/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Undetermined


Agency Contact:
Craig Street
Social Insurance Specialist
Social Security Administration
Office of Income Security Programs
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-9793

Lois A. Berg
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-1713
RIN: 0960-AG11
_______________________________________________________________________



SSA



162.  DENIAL OF TITLE II BENEFITS TO PERSONS FLEEING 
PROSECUTION, CUSTODY, OR CONFINEMENT, AND TO PERSONS VIOLATING 
PROBATION OR PAROLE (2222P)
Priority:


Other Significant. Major status under 5 USC 801 is undetermined.


Legal Authority:


42 USC 402(x)


CFR Citation:


Not Yet Determined


Legal Deadline:


None


Abstract:


These regulations will propose rules for prohibiting title II benefits 
to persons fleeing prosecution or custody, or confinement after 
conviction and to persons violating probation or parole. We will also 
propose rules for establishing that good cause exists for continuing to 
pay such benefits.


Statement of Need:


Public Law 108-203, the Social Security Protection Act of 2004, extends 
the fugitive felon nonpayment provision to title II beneficiaries 
effective January 2005. It also provides a good cause provision for 
titles II and XVI. The good cause provision requires the Commissioner 
to apply good cause if a court finds the person not guilty, charges are 
dismissed, a warrant for arrest is vacated, there are similar 
exonerating circumstances identified by the court, or the individual 
establishes that he or she was the victim of identity fraud and the 
warrant was issued on such basis. Public Law 108-

[[Page 72874]]

203 also gives the Commissioner the discretionary authority to 
establish good cause based on mitigating factors if the criminal 
offense is non-violent and not drug-related, and in the case of 
probation or parole violators, both the violation and the underlying 
offense are non-violent and not drug-related.


Summary of Legal Basis:


Section 203 of Public Law 108-203.


Alternatives:


None.


Anticipated Cost and Benefits:


There are no anticipated costs and benefits resulting from this 
regulatory action. Any program savings from nonpayment to fugitive 
felons will be the result of implementing Public Law 108-203.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           04/00/05
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Agency Contact:
Judy Sale
Social Insurance Specialist
Social Security Administration
Office of Income Support Programs
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-8581

Richard M. Bresnick
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235
Phone: 410 965-1758
RIN: 0960-AG12
_______________________________________________________________________



SSA



163.  PRIVACY AND DISCLOSURE OF OFFICIAL RECORDS AND 
INFORMATION; AVAILABILITY OF INFORMATION AND RECORDS TO THE PUBLIC 
(2562P)
Priority:


Other Significant


Legal Authority:


5 USC 552; 5 USC 552a; 42 USC 1306(a); 42 USC 902(a)(5)


CFR Citation:


20 CFR 401 app A(c)(4); 20 CFR 402.45(e)


Legal Deadline:


None


Abstract:


We propose to revise our privacy and disclosure rules to:


1. Add a new section to set out detailed procedures to further preserve 
the anonymity and protect the physical well-being of employees in 
abusive relationships or who fear for their physical well-being because 
of threats from others.


2. Conform SSA's Freedom of Information Act regulations in this respect 
more closely to Office of Personnel Management (OPM) regulations; and


3. Develop procedures for the protection in the electronic environment 
of personally identifiable information for at-risk employees.


Statement of Need:


The revised regulations are needed to:


1. Set out detailed procedures to ensure uniform application of the 
policy and equal protection for all at-risk employees;


2. Conform the regulations to our practice and systems of records, 
which set out guidelines to guard against the inappropriate release of 
personally identifiable information for at-risk employees; and


3. Describe the safeguards that ensure the appropriate procedures for 
the protection of personally identifiable information in the electronic 
environment.


Summary of Legal Basis:


Revisions are needed to incorporate into the regulations detailed 
procedures for the protection of personally identifiable information 
for at-risk employees.


Alternatives:


None.


Anticipated Cost and Benefits:


1. Develop uniform procedures for providing protection for all at-risk 
employees.


Cost--None.


Benefit--Protects the anonymity and physical well-being, as 
appropriate, of those at-risk employees who fear for their physical 
safety.


2. Conform the regulations more closely to the OPM regulations.


Cost--None.


Benefit--Regulatory guidelines will allow decision makers to use their 
own discretion to determine whether release of personally identifiable 
information would constitute an unwarranted invasion of personal 
privacy under the Freedom of Information Act, thereby placing employees 
at risk.


3. Description of safeguards against inappropriate disclosure of 
personal information by electronic means.


Cost--None.


Benefit--Increase employee awareness of the safeguards employed by SSA 
to maintain the security, confidentiality, and integrity of the 
information maintained for the well-being of all employees.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           07/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Edie McCracken
Social Insurance Specialist
Social Security Administration
Office of the General Counsel
Office of Public Disclosure
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-6117
RIN: 0960-AG14
_______________________________________________________________________



SSA

                              -----------

                            FINAL RULE STAGE

                              -----------




164. REVISED MEDICAL CRITERIA FOR EVALUATING MALIGNANT NEOPLASTIC 
DISEASES (399F)
Priority:


Other Significant

[[Page 72875]]

Legal Authority:


42 USC 405; 42 USC 902(a)(5); 42 USC 1383


CFR Citation:


20 CFR 404.1500, app 1


Legal Deadline:


None


Abstract:


Sections 13.00 and 113.00 (malignant neoplastic diseases) of appendix 1 
to subpart P of part 404 of our regulations (404.1501 through 404.1599) 
describe those impairments that are considered severe enough to prevent 
a person from doing any gainful activity, or for a child claiming SSI 
payments under title XVI, that causes marked and severe functional 
limitations. We are revising these sections to ensure that the medical 
evaluation criteria are up-to-date and consistent with the latest 
advances in medical knowledge and treatment. The Supplemental Security 
Income program incorporates and uses the same medical criteria as the 
Old-Age, Survivors, and Disability Insurance program.


Statement of Need:


These regulations are necessary to update the listings for evaluating 
malignant neoplastic diseases to reflect advances in medical knowledge, 
treatment and methods of evaluating these diseases. They ensure that 
determinations of disability have a sound medical basis, that claimants 
receive equal treatment through the use of specific criteria, and that 
individuals who are disabled can be readily identified and awarded 
benefits if all other factors of entitlement or eligibility are met.


Summary of Legal Basis:


Administrative-not required by statute or court order.


Alternatives:


In the NPRM, We proposed changes to the childhood listings for 
malignant solid tumors and neuroblastoma. As we reviewed our proposed 
changes in response to public comments, we realized that we need to 
further consider how to include these disorders in our listings. In the 
interim, we have decided to retain our current criteria for malignant 
solid tumors in children and neuroblastoma.


We also considered continuing to use current rules for malignant 
neoplastic diseases. However, we believe that proposing these revisions 
is preferable because of the medical advances that have been made in 
treating and evaluating these types of diseases. The current listings 
are now over 15 years old. Medical advances in disability evaluation 
and treatment and our program experience make clear that the current 
listings do not reflect state-of-the-art medical knowledge and 
technology.


Anticipated Cost and Benefits:


1. Title II


We estimate that, if finalized, these proposed rules would result in 
increased program outlays (in millions of dollars) to the title II 
program ($18 million total in a 10-year period beginning in fiscal year 
2004).


2. Title XVI


We estimate that, if finalized, these proposed rules will result in 
reduced program outlays resulting in the following program savings (in 
the millions of dollars) to the SSI program ($4 million total in a 10-
year period beginning in fiscal year 2004). (Note: Totals may not be 
equal to the sum of the annual totals due to rounding-out.)


(Note: Federal SSI payments due on October 1st in fiscal years 2006, 
2007, and 2012 are included with payments for the prior fiscal year.)


Administrative Savings-


We do not expect any administrative savings to result from these 
proposed regulations.


Administrative Costs-


We expect, if finalized, there will be some administrative costs 
associated with these proposed rules. If finalized, the proposed rules 
are expected to result in administrative costs less than 25 work years 
and less than $2 million per year.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            66 FR 59305                                    11/27/01
NPRM Comment Period End                                        01/28/02
NPRM Comment Per67 FR 19138ended                               04/18/02
Final Action                                                   01/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Michelle Hungerman
Social Insurance Specialist
Social Security Administration
Office of Disability Programs
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-2289

Suzanne DiMarino
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235
Phone: 410 965-1769
RIN: 0960-AD67
_______________________________________________________________________



SSA



165. ELIMINATION OF CLOTHING FROM THE DEFINITIONS OF INCOME AND IN-KIND 
SUPPORT AND MAINTENANCE, EXCLUSIONS OF ONE AUTOMOBILE, AND HOUSEHOLD 
GOODS AND PERSONAL EFFECTS UNDER SSI FROM RESOURCES (950F)
Priority:


Other Significant


Legal Authority:


Sec 1612 of the Social Security Act; Sec 1613(a)(2)(A) of the Social 
Security Act


CFR Citation:


20 CFR 416.1102 to 416.1104; 20 CFR 416.1121; 20 CFR 416.1124; 20 CFR 
416.1130; 20 CFR 416.1133; 20 CFR 416.1140; 20 CFR 416.1142; 20 CFR 
416.1144 to 416.1145; 20 CFR 416.1147 to 416.1149; 20 CFR 416.1157; 20 
CFR 416.1210; 20 CFR 416.1216; 20 CFR 416.1218


Legal Deadline:


None


Abstract:


We will make the following changes to our rules on determining income 
and resources under the Supplemental Security Income (SSI) program.


1. We will remove clothing from the definition of income and from the 
definition of in-kind support and maintenance. As a result, we 
generally will not count gifts of clothing as income when we decide 
whether a person can receive SSI benefits or when we compute the amount 
of benefits.

[[Page 72876]]

2. We will simplify our rules on how we exclude an automobile in 
determining the resources of a SSI applicant or recipient. 
Specifically, we will exclude one automobile from resources if it is 
used for transportation, without consideration of its value.


3. We will change our resources counting rules in the SSI program by 
eliminating the dollar value limit for the exclusion of household goods 
and personal effects. As a result, we would not count household goods 
and personal effects as resources when we decide whether a person can 
receive SSI benefits.


Statement of Need:


These changes will simplify our rules, making them less cumbersome to 
administer and easier for the public to understand and follow, thereby 
reducing the potential for payment errors. These changes also will make 
SSI financial eligibility rules more consistent with those of other 
means-tested Federal programs. The changes also will eliminate the need 
to ask claimants, beneficiaries, and other members of their households 
certain questions that have been viewed as intrusive. By no longer 
counting gifts of clothing as income, we will remove a disincentive for 
family members to help needy relatives.


Summary of Legal Basis:


None.


Alternatives:


Clothing -


None.


Automobile -


We considered revising the regulations to provide that SSA will assume 
that the recipient's automobile meets the use requirements for total 
exclusion of one automobile, absent evidence to the contrary. We did 
not select this option because it would not change the rule but only 
how we apply it. It does not go far enough in simplifying the SSI 
program. By revising the use requirements to exclude a car if it is 
used for transportation, thus replacing the four present specific 
transportation exclusion criteria, we will simplify the process.


We considered excluding the value of one automobile, regardless of use. 
We did not select this option because it would allow for the routine 
exclusion of an automobile even if it were not used for transportation. 
Such an approach would exclude an inoperable vehicle, a vehicle not 
being used at all, or a vehicle only used for recreation (such as a 
dune buggy). We maintain that it is unreasonable to exclude from 
resources the value of a vehicle that is not used for transportation.


We also considered increasing the excludable value of an automobile not 
meeting the use test to $11,000. We did not select this option because 
it would not simplify the SSI program.


Household Goods and Personal Effects -


Instead of excluding the entire value of household goods and personal 
effects, we considered raising the excludable limit to $10,000 from the 
current level of $2,000. We decided not to pursue this option because 
it would not provide any policy simplification. It would increase the 
amount excluded but it would not eliminate the need for the current 
time-consuming and complex procedures for determining the market value 
of an individual's household goods and personal effects.


Anticipated Cost and Benefits:


We estimate that the program costs and administrative costs for these 
regulatory changes would be negligible.


The proposed rules will simplify the administrative process of valuing 
noncash items. The change to the household goods and personal effects 
exclusion would simplify our rules and improve work efficiency by 
eliminating the need to inventory an individual's household goods and 
personal effects and determine their current market value. The changes 
will also serve to make our rules less intrusive and more protective of 
the dignity of individuals seeking SSI benefits.


Risks:


These changes will simplify complex SSI rules without disadvantaging 
SSI applicants or recipients or significantly increasing program or 
administrative costs.


Clothing -


There are no significant concerns.


Automobile -


Our experience shows that most SSI beneficiaries do not own expensive 
cars. Still, it is possible that a beneficiary may, under our proposal, 
own an automobile that is used for transportation (and therefore 
excluded) and that is worth a considerable amount of money.Household 
Goods and Personal Effects -


Under the proposed change to the household goods and personal effects 
exclusion, we would continue to recognize that individuals applying for 
SSI may own items that have investment value and which may be quite 
valuable. Such items as gems, jewelry, and collectibles would still be 
considered countable resources and subject to the SSI resource limit. 
Thus, the proposed exclusion for household goods and personal effects 
would not create an unintended exclusion for items that have investment 
value.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            69 FR 554                                      01/06/04
NPRM Comment Period End                                        03/08/04
Final Action                                                   12/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Albert Fatur
Social Insurance Specialist
Social Security Administration
Office of Income Security Programs
Office of Income Security Programs
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-9855

Robert J. Augustine
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-0020
RIN: 0960-AF84
_______________________________________________________________________



SSA



166. CONTINUATION OF BENEFIT PAYMENTS TO CERTAIN INDIVIDUALS WHO ARE 
PARTICIPATING IN A PROGRAM OF VOCATIONAL REHABILITATION SERVICES, 
EMPLOYMENT SERVICES, OR OTHER SUPPORT SERVICES (925F)
Priority:


Other Significant


Legal Authority:


42 USC 902(a)(5); 42 USC 425(b); 42 USC 1383(a)(6)


CFR Citation:


20 CFR 404.316; 20 CFR 404.327 (New); 20 CFR 404.328 (New); 20 CFR 
404.337;

[[Page 72877]]

20 CFR 404.352; 20 CFR 404.902; 20 CFR 404.1586; 20 CFR 404.1596; 20 
CFR 404.1597; 20 CFR 416.1320; 20 CFR 416.1331; 20 CFR 416.1338; 20 CFR 
416.1402


Legal Deadline:


None


Abstract:


These final rules revise the regulations that provide for the 
continuation of benefit payments to certain individuals who recover 
medically while participating in a vocational rehabilitation program 
with a State vocational rehabilitation agency. We are revising these 
regulations because of statutory amendments, which extend eligibility 
for these continued benefit payments to certain individuals who recover 
medically while participating in another appropriate program of 
vocational rehabilitation services. These include individuals 
participating in the Ticket to Work and Self-Sufficiency Program or 
another program of vocational rehabilitation services, employment 
services, or other support services approved by the Commissioner of 
Social Security.


Prior to November 1991, the Social Security Act provided for the 
continuation of payment of Social Security Disability Insurance and 
Supplemental Security Income disability and blindness benefits to 
individuals whose disability or blindness ended for medical reasons 
while they were participating in an approved State vocational 
rehabilitation program under title I of the Rehabilitation Act of 1973, 
if the Commissioner of Social Security determined that completion or 
continuation of the program would increase the likelihood of the 
individual's permanent removal from the disability benefit rolls. The 
Omnibus Budget Reconciliation Act of 1987 extended eligibility for 
continued benefits to individuals who receive Supplemental Security 
Income benefits based on blindness. (We implemented this change by 
issuing operating instructions effective April 1, 1988, the effective 
date of the amendment.) The Omnibus Budget Reconciliation Act of 1990 
extended eligibility for continued benefits to individuals 
participating in an approved non-State vocational rehabilitation 
program at the time their disability ended. (We implemented this change 
by issuing operating instructions effective November 1991, the 
effective date of the amendments.) The Personal Responsibility and Work 
Opportunity Reconciliation Act of 1996 requires the redetermination of 
eligibility based on disability of individuals who attain age 18, based 
on the rules for determining initial eligibility for adults. These 
redeterminations are not continuing disability reviews, however, we are 
revising our regulations to provide that an individual whose disability 
has ended as a result of an age-18 redetermination may qualify for 
continued benefits based on participation in an approved program and 
increased likelihood of permanent removal from the disability rolls, if 
the individual meets all other requirements for continued benefits. The 
Ticket to Work and Work Incentives Improvement Act of 1999 authorizes 
continued benefits for a person who medically recovers while 
participating in a program consisting of the Ticket to Work program or 
another program of vocational rehabilitation services, employment 
services, or other support services approved by the Commissioner of 
Social Security, provided that the other requirements for benefit 
continuation are met.


These final rules will also explain what we mean by ``an appropriate 
program of vocational rehabilitation services, employment services, or 
other support services.'' They will explain when an individual will be 
considered to be ``participating'' in the program. They will explain 
how we will determine whether an individual's completion of or 
continuation in an appropriate program of vocational rehabilitation 
services, employment services, or other support services will increase 
the likelihood that the individual will not have to return to the 
disability rolls. They will also explain that, for students age 18 
through 21, ``an appropriate program of vocational rehabilitation 
services, employment services, or other support services'' includes an 
individualized education plan developed under policies and procedures 
approved by the Secretary of Education for assistance to States for the 
education of children under the Individuals with Disabilities Education 
Act, as amended.


Statement of Need:


These final regulations are necessary to conform our regulations to 
amendments enacted in the Ticket to Work and Work Incentives 
Improvement Act of 1999, as well as the amendments enacted in the 
Omnibus Budget Reconciliation Act of 1990 and the Omnibus Budget 
Reconciliation Act of 1987; and as the result of a provision enacted in 
the Personal Responsibility and Work Opportunity Reconciliation Act of 
1996.


Summary of Legal Basis:


None.


Alternatives:


None.


Anticipated Cost and Benefits:


For the five-year period from fiscal year *2004 through 2008, the 
estimated effects on Federal Supplemental Security Income payments for 
increased payments for children range from $4 million in fiscal year 
2004 to $46 million in fiscal year 2008. The estimated impact on the 
Federal share of Medicaid payments during this five-year period range 
from $3 million in fiscal year 2004 to $41 million in fiscal year 2008.


*Updated estimates for the five-year period from fiscal 2005 through 
2009, are pending.


Risks:


At this time, we have not identified any risks associated with this 
proposal.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            68 FR 45180                                    08/01/03
NPRM Comment Period End                                        09/30/03
Final Action                                                   11/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


State


Agency Contact:
Barbara Leary
Social Insurance Specialist
Social Security Administration
Office of Employment Support Programs
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-7764

Suzanne DiMarino
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235
Phone: 410 965-1769
RIN: 0960-AF86

[[Page 72878]]

_______________________________________________________________________



SSA



167. ADMINISTRATIVE REVIEW PROCESS; INCORPORATION BY REFERENCE OF ORAL 
FINDINGS OF FACT AND RATIONALE IN WHOLLY FAVORABLE WRITTEN DECISIONS 
(964I)
Priority:


Other Significant


Legal Authority:


42 USC 405(a); 42 USC 405(b); 42 USC 902(a)(5); 42 USC 1383


CFR Citation:


20 CFR 404.953; 20 CFR 416.1453


Legal Deadline:


None


Abstract:


These interim final rules revise our regulations to provide that if an 
Administrative Law Judge (ALJ) enters a wholly favorable, oral decision 
into the record of a hearing, the ALJ may subsequently issue a written 
decision that gives the findings and reasons for the decision by 
incorporating by reference the findings and reasons stated orally at 
the hearing, provided that the ALJ does not determine subsequent to the 
hearing that the oral findings and reasons should be changed.


Statement of Need:


In fiscal year 2002, we announced a number of short-term actions to 
reduce delays in processing requests for ALJ hearings. One of these 
actions was to allow ALJs to issue oral decisions from the bench at the 
close of the hearing. We have found that ALJs are not frequently 
issuing oral decisions from the bench because of the duplication of 
work involved in issuing the oral decision and then subsequently 
issuing a written decision that fulfills existing provisions of our 
regulations requiring ALJs to issue written decisions that give the 
findings of fact and the reasons for the decision. We believe we can 
make it easier to use the bench decision procedure to reduce the time 
required to issue wholly favorable decisions by amending our 
regulations to explicitly authorize ALJs to issue wholly favorable 
written decisions that incorporate by reference the findings and 
rational stated orally in a bench decision.


Summary of Legal Basis:


None.


Alternatives:


Interpret our existing regulations to allow ALJs to issue written, 
wholly favorable decisions that give the findings of fact and rationale 
for the decision by incorporating by reference the findings and 
rationale stated in an oral decision that the ALJ entered into the 
record at the hearing.


Anticipated Cost and Benefits:


Improved public service by facilitating use of the oral decision 
procedure to reduce the time required to issue wholly favorable 
decisions.


The administrative savings resulting from these interim final rules 
have been determined to be negligible (i.e., less than $2 million or 25 
workyears).


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Interim Final Ru69 FR 61594                                    10/20/04
Interim Final Rule Comment Period End                          12/20/04
Final Action                                                   04/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Robert J. Augustine
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-0020
RIN: 0960-AF92
_______________________________________________________________________



SSA



168.  EXPANDED AUTHORITY FOR CROSS-PROGRAM RECOVERY OF BENEFIT 
OVERPAYMENTS (2221F)
Priority:


Other Significant. Major status under 5 USC 801 is undetermined.


Unfunded Mandates:


Undetermined


Legal Authority:


42 USC 404; 42 USC 405(a); 42 USC 902(a); 42 USC 1008; 42 USC 1010(a); 
42 USC 1320b-17; 42 USC 1383(b); 42 USC 1383(d)


CFR Citation:


20 CFR 404.530; 20 CFR 404.535; 20 CFR 404.540; 20 CFR 404.545; 20 CFR 
408.930; 20 CFR 408.931; 20 CFR 408.932; 20 CFR 408.933; 20 CFR 
416.570; 20 CFR 416.572; 20 CFR 416.573; 20 CFR 416.574; 20 CFR 416.575


Legal Deadline:


None


Abstract:


To implement section 210 of the Social Security Protection Act (SSPA) 
of 2004 (Pub. L. 108-203, enacted on March 2, 2004), we will revise our 
regulations on the recovery of overpayments incurred under one of our 
programs from benefits payable to the overpaid individual under other 
programs we administer. Provisions of the SSPA expand the authority for 
cross-program recovery of overpayments made in our various programs. 
These programs are Social Security benefits under title II of the 
Social Security Act (the Act), Special Veterans Benefits under title 
VIII of the Act and Supplemental Security Income (SSI) benefits under 
title XVI of the Act. Implementation of these regulatory revisions when 
they become effective will yield significant program savings.


Section 210 of the SSPA repealed 42 USC 1320b-18 and cross-program 
recovery provisions in 42 USC 1008 and amended 42 USC 1320b-17 of the 
Act. It allows recovery from monthly benefits generally at a rate not 
to exceed 10 percent of the monthly benefit and unlimited withholding 
of past-due benefits in one program to recover an overpayment paid 
under another program. It also allows for cross-program recovery even 
if the individual is entitled under the program in which the 
overpayment was made.


Statement of Need:


These revisions of our regulations are needed to implement section 210 
of the Social Security Protection Act (SSPA) of 2004.


Summary of Legal Basis:


These regulations implement section 210 of Public Law 108-203.


Alternatives:


None.

[[Page 72879]]

Anticipated Cost and Benefits:


We anticipate significant program savings (approximately $150 million 
over 5 years) because these final rules, will allow the Agency to 
recover more overpaid funds, and to recover them more quickly, than it 
could under prior statutory authority. The net administrative impact 
estimate is pending. Decisions regarding implementation are not final. 
However, any administrative impact is attributable to Public Law 108-
203 and not to this regulation.


Risks:


This regulation will protect the trust funds and general funds by 
recovering outstanding overpayments (paid under three titles of the 
Act) more quickly. It will also reduce the administrative cost of 
recontacting beneficiaries to attempt to obtain refunds of outstanding 
overpayments.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            69 FR 51962                                    08/24/04
NPRM Comment Period End                                        09/23/04
Final Action                                                   11/00/04
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


None


Agency Contact:
Robin Weber
Social Insurance Specialist
Social Security Administration
Office of Income Security Programs
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-7944

Richard M. Bresnick
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235
Phone: 410 965-1758
RIN: 0960-AG06
BILLING CODE 4191-02-S

[[Page 72880]]




CONSUMER PRODUCT SAFETY COMMISSION (CPSC)



Statement of Regulatory Priorities
 The U.S. Consumer Product Safety Commission is charged with protecting 
the public from unreasonable risks of death and injury associated with 
consumer products. To achieve this goal, the Commission:
 participates in the development or revision of voluntary 
            product safety standards;
 develops mandatory product safety standards or banning rules 
            when other, less restrictive, efforts are inadequate to 
            address a safety hazard;
 obtains repair, replacement, or refund of the purchase price 
            for defective products that present a substantial product 
            hazard; and
 develops information and education campaigns about the safety 
            of consumer products.
 When deciding which of these approaches to take in any specific case, 
the Commission gathers the best available data about the nature and 
extent of the hazard presented by the product. The Commission then 
analyzes this information to determine the best way to reduce the 
hazard in each case. The Commission's rules require the Commission to 
consider, among other factors, the following criteria when deciding the 
level of priority for any particular project:
 frequency and severity of injury;
 causality of injury;
 chronic illness and future injuries;
 costs and benefits of Commission action;
 unforeseen nature of the risk;
 vulnerability of the population at risk;
 probability of exposure to the hazard.
 Additionally, if the Commission proposes a mandatory safety standard 
for a particular product, the Commission is generally required to make 
statutory cost/benefit findings and adopt the least burdensome 
requirements that adequately protect the public.
 The Commission's statutory authority requires it to rely on voluntary 
standards rather than mandatory standards whenever a voluntary standard 
is likely to result in the elimination or adequate reduction of the 
risk of injury and it is likely that there will be substantial 
compliance with the voluntary standard. As a result, much of the 
Commission's work involves cooperative efforts with other participants 
in the voluntary standard-setting process rather than promulgating 
mandatory standards.
 In fiscal year 2005, the Commission's significant rulemaking 
activities will involve addressing risks of fire associated with 
ignition of upholstered furniture and mattresses and bedding.
 The emphasis on this rulemaking activity in the Commission's FY 2005 
regulatory plan is consistent with the Commission's statutory mandate 
and its criteria for setting priorities.
_______________________________________________________________________



CPSC

                              -----------

                          PROPOSED RULE STAGE

                              -----------




169. FLAMMABILITY STANDARD FOR UPHOLSTERED FURNITURE
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


15 USC 1193, Flammable Fabrics Act; 5 USC 801


CFR Citation:


16 CFR 1640


Legal Deadline:


None


Abstract:


On June 15, 1994, the Commission published an advance notice of 
proposed rulemaking (ANPRM) to begin a proceeding for development of a 
flammability standard to address risks of death, injury, and property 
damage from fires associated with ignition of upholstered furniture by 
small open-flame sources such as matches, lighters, or candles. CPSC 
staff conducted research and developed a draft flammability performance 
standard. The draft standard was first presented to stakeholders at a 
1996 ASTM voluntary standards meeting. The staff also worked with 
industry and voluntary standards groups to develop possible 
alternatives to a federal rule.


In 1998, the Commission held a public hearing to gather additional 
information beyond that available to the agency on the potential 
toxicity, health risks, and environmental effects associated with 
flame-retardant chemicals that might be used to meet a standard. In 
CPSC's 1999 appropriations legislation, Congress directed the 
Commission to contract with the National Academy of Sciences (NAS) for 
an independent study of potential health hazards associated with the 
use of flame retardant chemicals that might be used in upholstered 
furniture fabrics to meet a CPSC standard. The final NAS report was 
published in July 2000. The report concluded that of 16 flame-retardant 
chemicals reviewed, 8 could be used in upholstered furniture fabrics 
without presenting health hazards to consumers.


In 2002, the staff held a public meeting to receive any new technical 
information and recommendations from interested parties on the project. 
In 2003, the staff forwarded a package to the Commission analyzing the 
information received at the meeting and a package recommending that the 
Commission expand its proceeding to cover both small open flame and 
cigarette ignition risks.


On October 23, 2003, the Commission issued a new ANPRM expanding the 
scope of the proceeding to include both cigarette and small open flame-
ignited fire risks. The staff held a public meeting to discuss public 
comments on April 9, 2004. The staff is currently analyzing the 
comments and preparing alternatives for Commission consideration.


CPSC is also considering possible impacts of flame-retardant chemical 
use on worker safety and the environment. At the CPSC staff's request, 
the National Institute for Occupational Safety and Health studied 
potential worker exposure to and risks from certain flame-retardant 
chemicals that may be used by textile and furniture producers to comply 
with an upholstered furniture flammability standard. NIOSH 
preliminarily concluded that significant worker health effects were 
unlikely. CPSC staff is also working with the Environmental Protection 
Agency to develop a significant new use rule (SNUR) for flame-retardant 
compounds used in residential upholstered furniture fabrics under that 
agency's Toxic Substances Control Act Authority.


Statement of Need:


For 1995-1999, an annual average of approximately 6,600 residential 
fires in which upholstered furniture was the first item to ignite 
resulted in an estimated 460 deaths, 1,110 civilian injuries, and about 
$130 million in property damage that could be addressed by a 
flammability standard. The total annual societal cost

[[Page 72881]]

attributable to these upholstered furniture fire losses was 
approximately $2.75 billion. This total includes fires ignited by small 
open-flame sources and cigarettes.


Summary of Legal Basis:


Section 4 of the Flammable Fabrics Act (FFA) (15 U.S.C. 1193) 
authorizes the Commission to issue a flammability standard or other 
regulation for a product of interior furnishing if the Commission 
determines that such a standard is ``needed to adequately protect the 
public against unreasonable risk of the occurrence of fire leading to 
death or personal injury, or significant property damage.'' The 
Commission's regulatory proceeding could result in several actions, one 
of which could be the development of a mandatory standard requiring 
that upholstered furniture sold in the United States meet mandatory 
labeling requirements, resist ignition, or meet other performance 
criteria under test conditions specified in the standard.


Alternatives:


(1) The Commission could issue a mandatory flammability standard if the 
Commission finds that such a standard is needed to address an 
unreasonable risk of the occurrence of fire from ignition of 
upholstered furniture; (2) The Commission could issue mandatory 
requirements for labeling of upholstered furniture, in addition to, or 
as an alternative to, the requirements of a mandatory flammability 
standard; and (3) The Commission could terminate the proceeding for 
development of a flammability standard and rely on a voluntary standard 
if a voluntary standard would adequately address the risk of fire and 
substantial compliance with such a standard is likely to result.


Anticipated Cost and Benefits:


The estimated annual cost of imposing a mandatory standard to address 
ignition of upholstered furniture will depend upon the test 
requirements imposed by the standard and the steps manufacturers take 
to meet those requirements. Again, depending upon the test 
requirements, a standard may reduce cigarette and small open flame-
ignited fire losses, the total annual societal cost of which was over 
$3.3 billion for 1995-1999. Thus, the potential benefits of a mandatory 
standard to address the risk of ignition of upholstered furniture could 
be significant, even if the standard did not prevent all such fires.


Risks:


The estimated total annual cost to society from all residential fires 
associated with upholstered furniture was $3.3 billion for 1995-1999. 
Societal costs associated with upholstered furniture fires are among 
the highest associated with any product subject to the Commission's 
authority. A standard has the potential to reduce these societal costs.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           59 FR 30735                                    06/15/94
ANPRM Comment Period End                                       08/15/94
Staff Briefing of Commission on NPRM                           12/18/97
Commission Voted To Defer Action Pending Results of Toxicity He03/02/98
Commission Hearing May 5 & 6, 1998 on Possible Toxicity of Flame 
        Retardan63 FR 13017                                    03/17/98
NAS Study Completed (Required by Congress)                     07/10/00
Staff Sent Briefing Package to Commission                      11/01/01
Meeting Notice  67 FR 12916                                    03/20/02
Staff Held Public Meeting                                      06/18/02
Second Day of Public Meeting                                   06/19/02
Staff Sent Analysis of Information From Public Meeting to the 
        Commission                                             02/06/03
Staff Sent Regulatory Options to Commission                    07/12/03
Notice of Septem68 FR 51564ic Meeting                          08/27/03
Commission Decision                                            10/17/03
ANPRM           68 FR 60629                                    10/23/03
ANPRM Comment Period End                                       12/22/03
Staff Sends Briefing Package to Commission                     11/00/04
Staff Briefs Commission on Draft NPRM                          12/00/04
Commission DecisDetermined                                        To Be
NPRM            Determined                                        To Be
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Agency Contact:
Dale R. Ray
Project Manager
Consumer Product Safety Commission
Directorate for Economic Analysis
Washington, DC 20207
Phone: 301 504-7704
Email: [email protected]
RIN: 3041-AB35
_______________________________________________________________________



CPSC



170. PROPOSED STANDARD TO ADDRESS OPEN-FLAME IGNITION OF MATTRESSES/
BEDDING
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


15 USC 1193, Flammable Fabrics Act; 5 USC 801


CFR Citation:


16 CFR 1633


Legal Deadline:


None


Abstract:


On October 11, 2001, the Commission published an advance notice of 
proposed rulemaking (ANPRM) to begin a proceeding for development of a 
flammability standard to address risks of death, injury, and property 
damage from fires associated with ignition of mattresses/bedding by 
small open-flame sources such as lighters, candles, or matches. This 
ANPRM was issued after the Commission staff conducted a field 
investigation study of these incidents and worked with industry members 
to improve consumer information programs and conducted research to 
define and measure the fire hazard presented by mattress/bedding 
ignitions in residential fires.


The Commission also received four petitions from the Children's 
Coalition for Fire-Safe Mattresses proposing (1) an open flame standard 
similar to the full-scale test set forth in California Technical 
Bulletin 129, (2) an open flame standard similar to the component test 
set forth in British Standard 5852, (3) a warning label for mattresses 
warning of polyurethane foam fire hazards, and (4) a permanent, fire-
proof mattress identification tag. The Commission granted the first two 
petitions and denied the others.

[[Page 72882]]

The Commission staff reviewed public comments on the ANPRM and has 
continued working with the Sleep Products Safety Council (representing 
manufacturers and suppliers to the industry), the National Institute of 
Standards and Technology, the State of California Bureau of Home 
Furnishings, and others to complete the development of an appropriate 
test method and criteria for a standard to address open flame ignition 
of mattresses. The staff is preparing a decision package for Commission 
consideration, including a draft proposed standard with supporting 
materials, draft notice of proposed rulemaking (NPRM), and possible 
options to separately address the bedclothes contribution to mattress 
fires.


Statement of Need:


Based on national fire estimates for the years 1995-1999, ignition of 
mattresses and bedding resulted in an estimated 18,500 residential 
fires, 440 civilian deaths, 2,160 civilian injuries, and $259.5 million 
in property loss annually that could be addressed by a flammability 
standard. Since mattress fires often involve the ignition source of 
burning bedding, initially ignited by a smaller source, a standard 
incorporating an ignition source representing burning bedding could 
address deaths and injuries from fires caused by smoking materials, 
traditional small open flame sources, as well as other heat sources.


Summary of Legal Basis:


Section 4 of the Flammable Fabrics Act (FFA) (15 U.S.C. 1193) 
authorizes the Commission to issue a flammability standard or other 
regulation for a product of interior furnishing if the Commission 
determines that such a standard is ``needed to adequately protect the 
public against unreasonable risk of the occurrence of fire leading to 
death or personal injury, or significant property damage.'' The 
Commission's regulatory proceeding could result in the development of a 
mandatory standard requiring that mattresses sold in the United States 
meet mandatory labeling requirements and performance criteria limiting 
the size of the fire produced when a mattress is exposed to a large 
ignition source representing burning bedclothes.


Alternatives:


(1) The Commission could issue a mandatory flammability standard if the 
Commission finds that such a standard is needed to address an 
unreasonable risk of the occurrence of fire from ignition of 
mattresses;


(2) The Commission could issue mandatory requirements for labeling of 
mattresses, in addition to, or as an alternative to, the requirements 
of a mandatory flammability standard; or


(3) The Commission could terminate the proceeding for development of a 
flammability standard and rely on a voluntary standard if a voluntary 
standard would adequately address the risk of fire and substantial 
compliance with such a standard is likely to result.


Anticipated Cost and Benefits:


The estimated annual cost of imposing a mandatory standard to address 
ignition of mattresses by open-flame sources will depend upon the 
performance requirements imposed by the standard and the steps 
manufacturers take to meet those requirements. A standard incorporating 
an ignition source representing burning bedclothes could address deaths 
and injuries from fires caused by smoking materials, traditional small 
open flame sources, as well as other heat sources.


Risks:


The estimated total cost to society from all residential fires 
associated with mattresses/bedding was about $3 billion in 1999. 
Societal costs associated with mattress/bedding fires are among the 
highest associated with any product subject to the Commission's 
authority. A standard has the potential to reduce these societal costs.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           66 FR 51886                                    10/11/01
ANPRM Comment Period End                                       12/10/01
Staff Sent Briefing Package to Commission                      11/01/04
Staff Briefs Commission on NPRM Draft                          12/00/04
Commission DecisDetermined                                        To Be
NPRM            Determined                                        To Be
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Agency Contact:
Margaret L. Neily
Project Manager
Consumer Product Safety Commission
Directorate for Engineering Sciences
Washington, DC 20207
Phone: 301 504-7530
Email: [email protected]
RIN: 3041-AC02
BILLING CODE 6355-01-S

[[Page 72883]]




FEDERAL HOUSING FINANCE BOARD (FHFB)



Statement of Regulatory and Deregulatory Priorities
 The Federal Housing Finance Board (Finance Board) is an independent 
agency that is charged under the Federal Home Loan Bank Act (Bank Act) 
with supervising and regulating the Nation's Federal Home Loan Bank 
(Bank) System. The Bank System comprises 12 regional cooperative Banks 
that are owned by their respective member financial institutions. The 
Banks provide wholesale credit to members and certain nonmembers to be 
used for mortgage lending and related community lending activities. The 
Banks also acquire mortgage assets from members as a means of advancing 
their housing finance mission. The Bank System also includes the Office 
of Finance, which issues Bank System consolidated obligations. The 
Finance Board is required to prepare a regulatory plan pursuant to 
section 4 of Executive Order 12866. At this time, the Finance Board 
does not anticipate taking any significant regulatory or deregulatory 
actions during 2005 that would be required to be included in a 
regulatory plan.
The Finance Board's highest regulatory priorities during 2005 continue 
to be to ensure the safety and soundness of the Bank System and to 
ensure that the Banks fulfill their housing finance and community 
investment mission. In furtherance of these statutory mandates, the 
Finance Board expects to consider regulations that will:
 More clearly delineate the responsibilities and the 
            accountability of the board of directors for governance of 
            a Bank, thereby strengthening the role of the boards in the 
            Banks' operations;
 Streamline the Finance Board's review of new business 
            activities proposed by a Bank to more clearly focus the 
            regulatory review process on ensuring that a new product, 
            service, or activity will not endanger the continued safe 
            and sound operation of the Bank;
 Streamline the community support requirements to eliminate 
            unnecessary regulatory burden, while preserving the 
            statutory intent of ensuring that members' access to long-
            term advances reflects such factors as their record of 
            performance under the Community Reinvestment Act and their 
            record of lending to first-time homebuyers;
 Improve the operations and efficiency of the Affordable 
            Housing Program by more clearly delineating the Banks' 
            responsibilities for program administration and for 
            satisfying the statutory directive that the subsidy benefit 
            very low-income, low-income, and moderate-income 
            households.
BILLING CODE 6725-01-S

[[Page 72884]]




FEDERAL MARITIME COMMISSION (FMC)



Statement of Regulatory and Deregulatory Priorities
 The Federal Maritime Commission's (Commission) regulatory objectives 
are guided by the Agency's basic vision. The Commission's vision is to 
administer the shipping statutes as effectively as possible to provide 
fairness and efficiency in the United States maritime commerce. The 
Commission's regulations are designed to implement each of the statutes 
the Agency administers in a manner consistent with this vision in a way 
that minimizes regulatory costs, fosters economic efficiencies, and 
promotes international harmony.
 The Ocean Shipping Reform Act of 1998 (OSRA) continues to impact the 
Federal regulatory scheme regarding international ocean shipping. The 
legislation required new regulations, as well as the revision of many 
of the Commission's substantive regulations. One of the principal 
changes was the elimination of the requirement that carriers file 
tariffs with the Commission listing their rates and charges. Carriers 
are now required to publish their rates in private automated systems. 
The Commission continues to assess its regulations implementing this 
requirement, as well as other requirements of the new legislation.
 Common carriers remain concerned as to the content requirements of 
agreements filed with the Commission. Carriers have expressed a desire 
for better delineation as to what matters do or do not have to be filed 
and have suggested that the Commission's rules should provide 
protections for confidential business information, provide maximum 
flexibility for carriers to modify cooperative arrangements, and 
include guidance tailored for different types of agreements. The 
Commission instituted a rulemaking proceeding in calendar year 2003 to 
address these and other issues concerning the regulations governing 
agreements filed with the Commission. This matter continues to be 
assessed and will be finalized before the end of calendar year 2004. 
The Commission also oversees the financial responsibility of passenger 
vessel operators to indemnify passengers and other persons in cases of 
death or injury and to indemnify passengers for nonperformance of 
voyages. The Commission has received a number of comments in response 
to its rulemaking proposal to update the nonperformance coverage 
requirements to correspond more closely with current industry 
conditions. Included among these submissions is a 2004 request that the 
Commission consider a report providing an update on developments in the 
industry. The Commission is continuing its review of this request as 
well as the other matters submitted in this proceeding.
 The principal objective or priority of the Agency's current regulatory 
plan will be to continue to assess major existing regulations for 
continuing need, burden on the regulated industry, and clarity. The 
Commission has received requests from a segment of the common carrier 
community with regard to their tariff publishing obligations. The 
Commission has invited comments on these requests and is in the process 
of evaluating them. If the Commission determines to act favorably on 
these requests, it is possible there could be specific rulemaking 
proposals presented for the Commission's consideration.
 The Commission's review of existing regulations exemplifies its 
objective to regulate fairly and effectively while imposing a minimum 
burden on the regulated entities, following the principles stated by 
the President in Executive Order 12866.
Description of the Most Significant Regulatory Actions
 The Commission currently has no actions under consideration that 
constitute ``significant regulatory actions'' under the definition in 
Executive Order 12866.
BILLING CODE 6730-01-S

[[Page 72885]]




FEDERAL TRADE COMMISSION (FTC)



Statement of Regulatory Priorities
I. REGULATORY PRIORITIES
Background
 The Federal Trade Commission (FTC or Commission) is an independent 
agency charged with protecting American consumers from ``unfair methods 
of competition'' and ``unfair or deceptive acts or practices'' in the 
marketplace. The Commission strives to ensure that consumers benefit 
from a vigorously competitive marketplace. The Commission's work is 
rooted in a belief that free markets work -- that competition among 
producers and information in the hands of consumers bring the best 
products at the lowest prices for consumers, spur efficiency and 
innovation, and strengthen the economy.
 The Commission pursues its goal of promoting competition in the 
marketplace through two different, but complementary, approaches. 
First, for competition to thrive, curbing deception and fraud is 
critical. Through its consumer protection activities, the Commission 
seeks to ensure that consumers receive accurate, truthful, and non-
misleading information in the marketplace. At the same time, for 
consumers to have a choice of products and services at competitive 
prices and quality, the marketplace must be free from anticompetitive 
business practices. Thus, the second part of the Commission's basic 
mission--antitrust enforcement--is to prohibit anticompetitive mergers 
or other anticompetitive business practices without unduly interfering 
with the legitimate activities of businesses. These two complementary 
missions make the Commission unique insofar as it is the Nation's only 
Federal agency to be given this combination of statutory authority to 
protect consumers.
 The Commission is, first and foremost, a law enforcement agency. It 
pursues its mandate primarily through case-by-case enforcement of the 
Federal Trade Commission Act and other statutes. The Commission, 
however, is also charged with the responsibility of issuing and 
enforcing regulations under a number of statutes. Pursuant to the FTC 
Act, for example, the Commission currently has in place thirteen trade 
regulation rules. The Commission also has adopted a number of voluntary 
industry guides. Most of the regulations and guides pertain to consumer 
protection matters and are generally intended to ensure that consumers 
receive the information necessary to evaluate competing products and 
make informed purchasing decisions.
Industry Self-Regulation, Textile Leniency Policy, and Compliance 
Partnerships With Industry
 The Commission continues to be committed to protecting consumers by 
means that burden businesses the least. To that end, it has encouraged 
industry self-regulation, developed a corporate leniency policy for 
certain rule violations, and established compliance partnerships where 
appropriate.
 The Commission has issued reports that encourage industry self-
regulation in several areas. In the entertainment industry, the 
Commission has encouraged industry groups to improve their self-
regulatory programs to discourage the marketing of violent R-rated 
movies, Mature-rated electronic games and music labeling with a 
parental advisory to children. Recently, the Commission issued the 
latest of a series of reports on industry practices. The Commission 
recommended in its report that all three industries continue to improve 
compliance with existing ad placement guidelines and rating information 
practices and consider developing `best practices' to avoid advertising 
in venues popular with teen audiences. See Federal Trade Commission, 
Marketing Violent Entertainment to Children: A Fourth Follow-Up Review 
of Industry Practices in the Motion Picture, Music Recording & 
Electronic Game Industries (July 2004), http://www.ftc.gov/os/2004/07/
040708kidsviolencerpt.pdf. During the fall of 2003, the Commission 
sponsored a one-day workshop bringing together industry and parent and 
consumer groups to discuss the state of industry self regulation. See 
http://www.ftc.gov/bcp/workshops/violence/index/html. The Commission 
also continues to encourage companies in the alcohol industry to engage 
in self-regulation to ensure that advertising for products containing 
alcohol is not directed at underage youths. This year, the Commission 
will work with industry to facilitate compliance with the improved 
self-regulatory standards announced in the FTC's report, Alcohol 
Marketing and Advertising (Sept. 2003), http://ftc.gov/os/2003/09/
alcohol08report.pdf.
 In addition, in the weight-loss product advertising area, the 
Commission has proposed a strengthened self-regulatory response from 
the industry and more media responsibility to address the widespread 
problem of blatantly false efficacy claims. Specifically, the 
Commission authorized the release of a media reference guide to assist 
media in identifying facially false weight-loss claims. Federal Trade 
Commission Staff, Red Flag: A Reference Guide for Media on Bogus Weight 
Loss Claim Detection (2003), available at: http://www.ftc.gov/bcp/
online/pubs/buspubs/redflag.pdf. In addition, the FTC has supported a 
joint effort by the Electronic Retailing Association and the National 
Advertising Review Council to develop a self-regulatory, rapid review 
process to identify unsubstantiated claims in direct response to 
advertisements, such as infomercials.
 Also, with respect to the Children's Online Privacy Protection Act 
(COPPA), the Commission has approved the safe harbor programs of three 
organizations whose self-regulatory guidelines and programs protect 
children's privacy to the same or greater extent as COPPA.
 Recently, the Commission announced the Textile Corporate Leniency 
Policy Statement for minor and inadvertent violations of the Textile or 
Wool Rules that are self-reported by the company. 67 FR 71566 (Dec. 2, 
2002). Generally, the purpose of the Textile Corporate Leniency Policy 
is to help increase overall compliance with the rules while also 
minimizing the burden on business of correcting (through relabeling) 
inadvertent labeling errors that are not likely to cause injury to 
consumers. Under this policy, the Commission announced the factors that 
staff will consider in allowing the mislabeled goods to be sold without 
relabeling. The policy follows the Commission's Civil Penalty Leniency 
Program for small businesses, but is not limited to small businesses or 
situations involving civil penalties and excludes fraud cases. Since 
the Textile Corporate Leniency Program was announced, 25 companies have 
been granted ``leniency'' for self-reported minor violations of FTC 
textile regulations.
 The Commission has also engaged industry in compliance partnerships in 
at least two areas involving the funeral and franchise industries. 
Specifically, the Commission's Funeral Rule Offender Program, conducted 
in partnership with the National Funeral Directors Association, is 
designed to educate funeral home operators found in violation of the 
requirements of the Funeral Rule, 16 CFR part 453, so that they can 
meet the rule's disclosure requirements. Approximately 215 funeral 
homes have participated in the program since its inception in 1996. In

[[Page 72886]]

addition, the Commission established the Franchise Rule Alternative Law 
Enforcement Program in partnership with the International Franchise 
Association (IFA), a nonprofit organization that represents both 
franchisors and franchisees. This program is designed to assist 
franchisors found to have a minor or technical violation of the 
Franchise Rule, 16 CFR part 436, in complying with the rule. Violations 
involving fraud or other section 5 violations are not candidates for 
referral to the program. The IFA teaches the franchisor how to comply 
with the rule and monitors its business for a period of years. Where 
appropriate, the program will offer franchisees the opportunity to 
mediate claims arising from the law violations. Since December 1998, 
fourteen companies have agreed to participate in the program.
New Rulemakings Required by Statute
Since the Commission's 2003 Regulatory Plan was published, the Congress 
enacted several laws requiring the Commission to undertake rulemakings 
and studies. These include at least 25 new rulemakings and eight 
studies required by the Fair and Accurate Credit Transactions Act of 
2003, Pub. L. No. 108-159 (FACTA or the FACT Act); the rulemaking and 
study required by the Fairness to Contact Lens Consumers Act of 2003, 
Pub. L. No. 108-64; the rulemakings and reports required by the 
Controlling the Assault of Non-Solicited Pornography and Marketing Act 
of 2003, Pub. L. No. 108-187 (CAN-Spam Act); and the rulemaking 
pursuant to the Federal Deposit Insurance Corporation Improvements Act 
of 1991. Pub. L. 102-242. These rulemakings are proceeding according to 
schedule and are detailed more extensively in the Unified Agenda.
Ten-Year Review Program
 In 1992, the Commission implemented a program to review its rules and 
guides regularly. The Commission's review program is patterned after 
provisions in the Regulatory Flexibility Act, 5 USC 601-612. Under the 
Commission's program, however, rules have been reviewed on a ten-year 
schedule as resources permit. For many rules this has resulted in more 
frequent reviews than is generally required by section 610 of the 
Regulatory Flexibility Act. This program is also broader than the 
review contemplated under the Regulatory Flexibility Act, in that it 
provides the Commission with an ongoing systematic approach for seeking 
information about the costs and benefits of its rules and guides and 
whether there are changes that could minimize any adverse economic 
effects, not just a ``significant economic impact upon a substantial 
number of small entities.'' 5 USC 610. The program's goal is to ensure 
that all of the Commission's rules and guides remain beneficial and in 
the public interest. It complies with the Small Business Regulatory 
Enforcement Act of 1996, Pub. L. 104-121. This program is consistent 
with the Administration's ``smart'' regulation agenda to streamline 
regulations and reporting requirements and Section 5(a) of Executive 
Order 12866, 58 FR 51735 (Sept. 30, 1993).
 As part of its continuing ten-year plan, the Commission examines the 
effect of rules and guides on small businesses and on the marketplace 
in general. These reviews often lead to the revision or rescission of 
rules and guides to ensure that the Commission's consumer protection 
and competition goals are achieved efficiently and at the least cost to 
business. In a number of instances, the Commission has determined that 
existing rules and guides were no longer necessary nor in the public 
interest. As a result of the review program, the Commission has 
repealed 48 percent of its trade regulation rules and 57 percent of its 
guides since 1992.
Calendar Year 2004-05 Reviews
 All of the matters currently under review pertain to consumer 
protection and are intended to ensure that consumers receive the 
information necessary to evaluate competing products and make informed 
purchasing decisions. During early 2004, the Commission published a 
revised timetable for its regulatory review program deferring all 
review for one year because of ongoing review proceedings as well as 
the addition of at least 27 rulemakings required by new legislation. 69 
FR 3867 (Jan. 27, 2004). In January 2005, the Commission plans to 
publish a notice announcing the new rules and guides, if any, that will 
be reviewed during 2005.
Ongoing Reviews
 As part of the Commission's ten-year review program, in 2003 the 
Commission continued reviews of eight rules, two guides, and one 
interpretation. It is expected that during the spring of 2005, the 
Commission will issue separate notices requesting comments both on the 
Statement of General Policy or Interpretations under the Fair Credit 
Reporting Act (also known as FCRA Commentary) and for the Guides 
Concerning the Use of Endorsements and Testimonials in Advertising. 
Other reviews are proceeding.
 First, with respect to the Premerger Notification and Report Form, the 
Commission issued a Notice of Proposed Rulemaking (NPRM) to reconcile, 
as far as practical, the current disparate treatment of corporations, 
partnerships, limited liability companies, and other types of non-
corporate entities under the rules. See 69 FR 18686 (Apr. 8, 2004). The 
staff expects to forward its recommendation about this issue to the 
Commission by the end of 2004 or early 2005. In the same time frame, 
the Commission anticipates amending the Hart-Scott-Rodino Rules to 
allow parties to file the premerger notification and report form 
electronically via the Internet.
 Second, in the review of the Franchise Rule, 16 CFR part 436, the 
Commission announced on August 25, 2004, the issuance of a staff 
report, ``Disclosure Requirements and Prohibitions Concerning 
Franchising,'' which summarizes the rulemaking record to date, analyzes 
the various alternatives, and sets forth the staff's recommendations to 
the Commission on the various proposed amendments to the Franchise 
Rule, 69 FR 53661 (Sept. 2, 2004). Among other things, staff proposes 
that the Commission retain the Franchise Rule while updating it to 
account for new technologies and to provide prospective franchisees 
with more disclosure about the nature of the franchise relationship, 
while minimizing the discrepancies between Federal and State law. 
Public comments are being accepted until November 12, 2004. Staff will 
review the comments and anticipates sending its recommendation to the 
Commission in late 2005. The Commission did not review or approve the 
staff report.
 Third, in the review of the R-Value Rule for home insulation, 16 CFR 
part 460, the Commission reviewed the comments received on the Advance 
Notice of Proposed Rulemaking (ANPRM) and issued an NPRM, which 
announced a number of proposed amendments to the rule. 68 FR 41872 
(July 15, 2003). After assessing the public comments, staff expects to 
forward its recommendation to the Commission regarding substantive 
amendments to the rule by late 2004.
 Fourth, for the rulemaking on Privacy of Consumer Financial 
Information, 16 CFR part 313, the Commission and banking agencies 
published an ANPRM and requested public comments on a variety of 
subjects including the goals, language, and mandatory or permissible

[[Page 72887]]

aspects of privacy notices. 68 FR 75164 (Dec. 30, 2003). Since the 
issuance of rules in 2000 in accordance with Gramm-Leach-Bliley Act, 15 
USC 6801 et seq., requirements that financial institutions provide 
notice of their privacy policies to their customers, the agencies have 
been trying to develop more useful privacy notices to consumers. The 
comment period for the ANPRM ended on March 26, 2004. Staff for the 
agencies are reviewing comments and continuing to work together to 
determine the next steps.
 Fifth, the Commission's review of the Pay-Per-Call Rule, 16 CFR part 
308, is ongoing. The Commission has held workshops to discuss proposed 
amendments to this rule, including provisions to combat telephone bill 
``cramming''--inserting unauthorized charges on consumers' phone 
bills--and other abuses in the sale of products and services that are 
billed to the telephone including voicemail, 900-number services, and 
other telephone based information and entertainment services. The most 
recent workshop focused on discussions of the use of 800 and other 
toll-free numbers to offer pay-per-call services, the scope of the 
rule, the dispute resolution process, the requirements for a 
presubscription agreement, and the need for obtaining express 
authorization from consumers before placing charges on their telephone 
bills. Staff anticipates forwarding its recommendation to the 
Commission during the spring of 2005.
 Sixth, the Commission's review of the Regulations Under the 
Comprehensive Smokeless Tobacco Health Education Act of 1986 (Smokeless 
Regulations), 16 CFR part 307, is ongoing. The Smokeless Regulations 
govern the format and display of statutorily mandated health warnings 
on all packages and advertisements for smokeless tobacco. In fiscal 
year 2000, the Commission undertook its periodic review of the 
Smokeless Regulations to determine whether the Regulations continue to 
effectively meet the goals of the Act and to seek information 
concerning the regulations' economic impact in order to decide whether 
they should be amended. Staff is currently assessing the public 
comments and anticipates forwarding its recommendations to the 
Commission by April 2005.
 Finally, the Commission began its regulatory review of certain aspects 
of the Funeral Industry Practices Rule (Funeral Rule), 16 CFR part 453, 
in 1999. The Funeral Rule, which became effective in 1984, and was 
amended in 1994, requires providers of funeral goods and services to 
give consumers itemized lists of funeral goods and services that state 
prices and descriptions and also contain specific disclosures. The rule 
enables consumers to select and purchase only the goods and services 
they want, except for those that may be required by law and a basic 
services fee. Also, funeral providers must seek authorization before 
performing some services, such as embalming. In addition to an 
assessment of the rule's overall costs and benefits and continuing need 
for the rule, the review will examine whether changes in the funeral 
industry warrant broadening the scope of the rule to include non-
traditional providers of funeral goods or services and revising or 
clarifying certain prohibitions in the rule. See 64 FR 24250 (May 5, 
1999). In response to requests of industry members, the Commission 
determined to extend the comment period. A public workshop conference 
was subsequently held to explore issues raised in the comments 
submitted. Staff expects to forward its recommendation to the 
Commission by July 2005.
Final and Other Actions
 Since publication of the 2003 Regulatory Plan, the Commission has 
taken final actions on several rulemakings. After amending the 
Telemarketing Sales Rule (TSR), 16 CFR part 310 (68 FR 4580, Jan. 29, 
2003), to establish a national ``do not call'' registry, the Commission 
opened the registry on June 26, 2003. Consumers can register for free 
in two ways: online at DONOTCALL.GOV or by telephone at 1(888) 382-
1222. As of October 1, 2003, it became illegal for most telemarketers 
to call a number listed on the registry. Also, the Commission issued 
additional amendments to the TSR on July 31, 2003, that imposed fees on 
entities accessing the ``do not call'' registry. See 68 FR 45134.
 The Consolidated Appropriations Act of 2004, Pub. L. No. 108-199, 
required that the Commission amend the TSR to require telemarketers 
subject to the TSR to access the ``do-not-call'' lists once a month 
rather than every three months. The Commission has implemented these 
provisions by promulgating regulations, effective January 1, 2005, 
requiring the telemarketers to scrub their lists at least every 31 
days. 69 FR 16368 (Mar. 29, 2004).
 Also pursuant to the Consolidated Appropriations Act of 2004, the Do-
Not-Call Implementation Act, Pub. L. No. 108-10 (2003), and the 
Telemarketing Fraud and Abuse Prevention Act, 15 USC 6101-08, the 
Commission published an NPRM that would amend the TSR to revise fees 
charged for industry access to the national ``do-not-call'' registry. 
69 FR 23701 (Apr. 30, 2004). In addition, the Commission has 
promulgated a new fee structure for accessing the ``do-not-call'' lists 
that became effective September 1, 2004. See 69 FR 45580 (July 30, 
2004). Under the new fee structure, the annual fee for each area code 
of data accessed will be $40, and the maximum amount that any entity 
would be charged -- for access to 280 area codes of data or more would 
be $11,000. The final rule continues to allow all entities accessing 
the Registry to obtain the first five area codes of data for free and 
allows those entities exempt from the Registry's requirements to obtain 
access at no charge.
 Second, on February 4, 2004, the Commission published a Federal 
Register notice announcing that it would retain the Trade Regulation 
Rule on Ophthalmic Practice Rules (Eyeglass Rule) in its present form. 
69 FR 5451. In that notice, the Commission also discussed the comments 
received in response to the Commission's request for comments on the 
rule and analyzed the effect of the Fairness to Contact Lens Consumers 
Act, 15 USC 7601-7610, on the Eyeglass Rule. A separate Federal 
Register Notice, also published on February 4, 2004, containing an NPRM 
under the Fairness to Contact Lens Consumers Act, makes two clerical 
amendments to the Eyeglass Rule, which clarify the distinction between 
that rule and the proposed Contact Lens Rule. 69 FR 5440, 5450. On July 
2, 2004, the Commission issued its final Contact Lens Rule as required 
by the Fairness to Contact Lens Consumers Act. 69 FR 40482.
 Third, as required by the CAN-SPAM Act of 2003, the Commission issued 
a rule prescribing that a mark be included in commercial e-mail that 
contains sexually oriented materials. 69 FR 21024 (Apr. 19, 2004). This 
rule went into effect on May 19, 2004. The Commission is also required 
to issue a rule defining the relevant criteria to facilitate the 
determination of the ``primary purpose'' of an electronic message by 
December 6, 2004. See 69 FR 11776 (Mar. 11, 2004) (ANPRM); 69 FR 50091 
(Aug. 13, 2004) (NPRM). Besides other CAN-SPAM related discretionary 
rulemakings that are ongoing, the Commission is also required to issue 
four separate reports to the Congress within the next two years.
 Fourth, the Commission has actively been issuing, sometimes in 
conjunction

[[Page 72888]]

with other federal agencies, rules according to the statutory mandate 
of the FACT Act. First, on December 24, 2003, the Commission and the 
Board of Governors of the Federal Reserve System (the Federal Reserve 
Board) jointly adopted Interim Final Rules that established December 
31, 2003, as the effective date for provisions of the Act that 
determine the relationship between the Fair Credit Reporting Act (FCRA) 
and state laws and provisions that authorize rulemakings or other 
implementing actions by agencies. 68 FR 74467. On February 11, 2004, 
these Interim Final Rules were made final. Also, on that date, the 
Commission and the Federal Reserve Board published joint final rules 
that established a schedule of effective dates for many of the 
provisions of the FACT Act for which the Act itself did not 
specifically provide an effective date. 69 FR 6526. On February 24, 
2004, the Commission published an Interim Final Rule effective on March 
3, 2004, that prohibited consumer reporting agencies from avoiding 
treatment as nationwide consumer reporting agencies. 69 FR 8532. The 
Commission requested comments on that Interim Final Rule, and the 
comment period closed on April 23, 2004.
 On May 20, 2004, the Commission issued a final rule effective on June 
21, 2004, making technical changes to earlier rules, establishing a 
general organizational scheme for subchapter F of chapter I of title 16 
of the Code of Federal Regulations, and setting forth general 
provisions applicable to all FTC rules under the FCRA. 69 FR 29061. On 
June 24, 2004, the FTC issued a final rule effective on December 1, 
2004, for the provision of free consumer reports to consumers, 
including (1) a central source whereby consumers can make one request 
and receive their consumer report from each of the three major 
nationwide consumer reporting agencies and (2) rules with respect to 
the provision of free consumer reports by ``nationwide specialty 
consumer reporting agencies, '' as defined in the new FCRA section 
603(w). 69 FR 35468 (June 24, 2004).
 By December 2004, the FTC must promulgate, in coordination with the 
Federal Reserve Board, the Office of the Comptroller of the Currency, 
the Federal Deposit Insurance Corporation, the Office of Thrift 
Supervision, the National Credit Union Administration, and the 
Securities and Exchange Commission, rules (1) providing for the proper 
disposal of consumer report information, 69 FR 21388 (Apr. 20, 2004) 
(NPRM); (2) governing consumers' new right to opt out of marketing by 
affiliates, 69 FR 33324 (June 15, 2004) (NPRM); 69 FR 43546 (July 21, 
2004) (Extension of Comment Period); and (3) improving the required 
notice to consumers regarding their right to opt out of prescreened 
solicitations. 69 FR 58861 (Oct. 1, 2004) (NRPM). Although there is no 
statutory deadline, the FTC must also issue a rule (1) setting the 
required duration of the new active duty fraud alert; and (2) defining 
certain terms that are relevant to new identity theft victims' rights. 
69 FR 23370 (Apr. 28, 2004) (NPRM). The Commission issued the final 
rule on October 29, 2004, 69 FR 63922. The FTC is also required to 
promulgate a summary of consumers' identity theft rights, 69 FR 42616 
(July 16, 2004) (Proposed Summaries and Notices), and to amend the 
existing general summary of consumer rights to include consumers' 
rights to a credit score and free annual credit report. The Commission 
expects to do so by December 2004.
Fifth, as part of the Commission's regulatory review program, on March 
3, 2003, staff requested public comments on the economic impact and 
benefits of the Rules and Rules and Regulations under the Hobby 
Protection Act and whether changes in the relevant technologies -- such 
as e-mail and the Internet -- affect the rule since it was issued. 68 
FR 9856. On March 3, 2004, the Commission retained the Hobby Protection 
Act Regulations without amendment. 69 FR 9943.
 Sixth, in the review of the Labeling Requirements for Alternative 
Fuels and Alternative-Fueled Vehicles, 16 CFR part 309, the Commission 
requested comments about the need to retain the rule and specific 
options for modifying the alternative-fueled-not-including hybrids-
vehicle label in light of new Environmental Protection Agency (EPA) 
tailpipe standards. See 69 FR 55332 (Sept. 14, 2004). After assessing 
the public comments, the Commission amended the rule to delete vehicle-
specific information from the labels and added a reference to the EPA's 
green vehicle guide website, http://www.epa.gov/greenvehicle, which 
provides detailed comparative information about vehicle emissions 
generally and by vehicle model. 69 FR 55332 (Sept. 14, 2004). The 
amendment will become effective on March 31, 2005.
 Lastly, for the review of the Tire Advertising and Labeling Guides 
(Tire Guides), the Commission issued a notice seeking public comment 
about, among other things, whether there is a continuing need for the 
Tire Guides and what changes, if any, should be made to them to 
increase the benefits of the Guides to purchasers. 68 FR 50984 (Aug. 
25, 2003). On September 17, 2004, the Commission announced the repeal 
of the Tire Guides. 69 FR 56932 (Sept. 23, 2004).
Summary
 In both content and process, the FTC's ongoing and proposed regulatory 
actions are consistent with the President's priorities. The actions 
under consideration inform and protect consumers and reduce the 
regulatory burdens on businesses. The Commission will continue working 
toward these goals. The Commission's ten-year review program is 
patterned after provisions in the Regulatory Flexibility Act and 
complies with the Small Business Regulatory Enforcement Fairness Act of 
1996. The Commission's ten-year program also is consistent with section 
5(a) of Executive Order 12866, 58 FR 51735 (Sept. 30, 1993), which 
directs executive branch agencies to develop a plan to reevaluate 
periodically all of their significant existing regulations. In 
addition, the Telemarketing Sales Rule, 16 CFR part 310 (2003), is 
consistent with the President's Statement of Regulatory Philosophy and 
Principles, Executive Order 12866, section 1(a), which directs agencies 
to promulgate only such regulations as are, inter alia, required by law 
or are made necessary by compelling public need, such as material 
failures of private markets to protect or improve the health and safety 
of the public.
 As set forth in Executive Order 12866, the Commission continues to 
identify and weigh the costs and benefits of proposed actions and 
possible alternative actions, and to receive the broadest practicable 
array of comment from affected consumers, businesses, and the public at 
large. As stated above, since 1992 the Commission has repealed 48 
percent of its trade regulation rules and 57 percent of its industry 
guides that existed in 1992 because they had ceased to serve a useful 
purpose. In sum, the Commission's regulatory actions are aimed at 
efficiently and fairly promoting the ability of ``private markets to 
protect or improve the health and safety of the public, the 
environment, or the well-being of the American people.'' Executive 
Order 12866, section 1.
Rulemakings that Respond to Public Regulatory Reform Nominations

[[Page 72889]]

During March 2002, OMB requested public nominations for regulatory 
reforms. The Office of Information and Regulatory Affairs (OIRA) 
conducted a preliminary review of the public comments received and 
found five FTC activities that one or more commenters had nominated for 
reform. In a March 7, 2003 letter, the FTC responded that the agency 
systematically reviews all regulations and guides on a ten-year basis 
and explained how the agency had already reviewed or was about to 
review the activity at issue or why some of the other activities were 
not good candidates for reform as contemplated by the Smarter 
Regulations Report.
II. REGULATORY ACTIONS
 The Commission does not plan to propose any rules that would be a 
``significant regulatory action'' under the definition in Executive 
Order 12866.
BILLING CODE 6750-01-S

[[Page 72890]]




NATIONAL INDIAN GAMING COMMISSION (NIGC)



Statement of Regulatory Priorities
 The Indian Gaming Regulatory Act (IGRA or the Act), 25 U.S.C. 2701 et 
seq., was signed into law on October 17, 1988. The Act established the 
National Indian Gaming Commission (NIGC or the Commission). The stated 
purpose of the Commission is to regulate the operation of gaming by 
Indian tribes as a means of promoting tribal economic development, 
self-sufficiency, and strong tribal governments. It is the Commission's 
intention to provide regulation of Indian gaming to adequately shield 
it from organized crime and other corrupting influences, to ensure that 
the Indian tribe is the primary beneficiary of the gaming operation, 
and to assure that gaming is conducted fairly and honestly by both the 
operator and players.
 The regulatory priorities for the next fiscal year reflect the 
Commission's commitment to upholding the principles of IGRA. The gaming 
industry changes rapidly with advancements in machine technology. It is 
crucial for the vitality of Indian gaming that regulators have the 
ability to respond quickly to these changes. To that end, the 
Commission has decided that the development of technical standards for 
game classifications, gaming machines, and related gaming systems is an 
important initiative for the promotion and protection of tribal gaming.
 Additionally, the Commission will be making technical amendments to 
the minimal internal control standards. These amendments will correct 
isolated problems that have been brought to the Commission's attention 
by tribal gaming operators and regulators.
 The Commission has been innovative in using active outreach efforts to 
inform its generic policy development and its rulemaking efforts. For 
example, the Commission has had great success in using regional 
meetings, both formal and informal, with tribal governments to gather 
views on current and proposed Commission initiatives. The Commission 
anticipates that these consultations with regulated tribes will play an 
important role in the development of technical standards.
BILLING CODE 7565-01-S
